A head-to-head study,
published in the June Journal of Child and Adolescent Psychopharmacology,
confirms that Focalin(R) XR (dexmethylphenidate HCl) extended-release
capsules offer greater improvements in managing symptoms of Attention
Deficit/Hyperactivity Disorder compared with Concerta(R) (d,l-
methylphenidate HCl) extended-release tablets at two hours post-dose, the
primary study endpoint.
Focalin XR 20 mg and 30 mg2 also demonstrated better symptom control
versus Concerta 36 mg and 54 mg respectively, from 30 minutes to 6 hours.
Symptom control was demonstrated as early as 30 minutes post-dose with
Focalin XR 20 mg and 30 mg versus placebo. Neither dose of Concerta was
effective versus placebo at 30 minutes. Novartis is seeking revised
labeling to reflect the 30-minute onset of action.
"There are many things to consider when determining which treatment is
best for a patient, including lifestyle implications," said Alice Mao,
M.D., Associate Professor of Psychiatry at the Baylor College of Medicine.
"The results of this study demonstrate the benefits of Focalin XR during
the early part of the day, which may be better for children who need their
medication to begin working before they leave for school and continue
working throughout the day."
Attention Deficit/Hyperactivity Disorder affects approximately three to
seven percent of children in the United States, and its symptoms --
inattention, hyperactivity and impulsivity -- can significantly impact a
child's ability to focus and learn in an educational setting. The study
included children between the ages of 6 and 12 and examined their response
to Focalin XR compared to Concerta as well as placebo in a classroom
setting.
Similar efficacy was observed between Focalin XR and Concerta at eight
hours post-dose. Only at 10 to 12 hours and 11 to 12 hours post-dose did
Concerta 36 mg and 54 mg demonstrate symptom improvement over Focalin XR 20
mg and 30 mg respectively.
"Focalin XR helps children with ADHD optimize their natural cycle of
the day because its drug delivery system allows for a quick onset in the
morning, effective symptom management during the day, and then tapers off
in the evening," said Rafael Muniz, MD, Senior Medical Director, Novartis
Pharmaceuticals Corporation.
Focalin XR uses the proprietary SODAS(R) (Spheroidal Oral Drug
Absorption System) technology developed by Elan Corporation, where 50% of
the dose is released immediately and the remaining 50% is released after
approximately four hours, resulting in a maximum peak at about 1.5 hours
and a second peak at about 6.5 hours. Concerta is formulated to release 22%
of the drug initially, with the remainder released through a controlled
osmotic process.
In addition, Focalin XR and Concerta have chemical differences. Focalin
XR isolates the active d-isomer of d,l-methylphenidate. Therefore, only
half the dose of methylphenidate is required. Concerta is a
d,l-methylphenidate.
Study Results
The randomized, multi-center, double-blind, five-period, crossover
study was conducted in 84 children with ADHD with 6-12 years of age,
stabilized on methylphenidate and randomized to different treatment
sequences for comparison. The study was conducted in a laboratory classroom
setting over a 12 hour period. The crossover design exposed each child to
five treatments: Focalin XR (20 mg/day and 30 mg/day), Concerta (36 mg/day
and 54 mg/day) and placebo.
Primary efficacy was measured by the change from pre-dose in the
Swanson, Kotkin, Agler, Mylnn, and Pelham (SKAMP) Rating Scale-Combined
scores at two hours post-dose with Focalin XR 20 mg compared with Concerta
36 mg. The SKAMP rating scale is a standard assessment tool used in
laboratory classroom clinical trials to evaluate attention and behavior.
Both doses of Focalin XR showed significantly greater improvement in
SKAMP-Attention and -Deportment scores when compared with placebo at all
measured time-points (30 minutes to 12 hours post-dose), except for 10-12
hours post-dose with 20 mg. Concerta 36 mg and 54 mg demonstrated efficacy
at measured time-points 1-12 hours post-dose, but were no different to
placebo at 30 minutes.
Because of the differences in release profiles, the investigators also
studied overall efficacy during the 12 hour study period using an area
under the curve analysis (AUC0-12) of the SKAMP combined scores. All doses
of the active medication were significantly better than placebo. There was
no difference between Focalin XR 20 mg and 30 mg when compared to both
Concerta 36 mg and 54 mg, respectively, observed overall across the 12-hour
day.
In general, both treatments were well tolerated and no patients
discontinued or had a reduction in study drug dose due to an adverse event.
A total of 81 children completed the study (three withdrew consent for
reasons not related to study medications).
A previous head-to-head study comparing Focalin XR and Concerta
published in the April 2008 Psychopharmacology Bulletin found similar
efficacy and safety results to the present study.
About Focalin XR
Focalin XR (dexmethylphenidate HCl) extended-release capsules are
indicated for the treatment of Attention Deficit/Hyperactivity Disorder
(ADHD) in adults, adolescents and children six years and older. Focalin XR
is indicated as an integral part of a total treatment program for ADHD that
may include other measures (e.g., psychological, educational, social) for
patients with this syndrome.
Important Safety Information
The most common adverse events seen with Focalin XR were dyspepsia,
decreased appetite, headache and anxiety in pediatric studies; and dry
mouth, dyspepsia, feeling jittery, dizziness, headache and anxiety in adult
studies.
Focalin XR is contraindicated in patients with marked anxiety, tension
and agitation since the drug may aggravate these symptoms; in patients
known to be hypersensitive to methylphenidate or other components of the
product; in patients with glaucoma; in patients with motor tics or with a
family history or diagnosis of Tourette's syndrome; and during or following
treatment with monoamine oxidase inhibitors.
Stimulants should generally not be used in children, adolescents or
adults with known serious structural cardiac abnormalities, cardiomyopathy,
serious heart-rhythm abnormalities or other serious cardiac problems. Use
with caution in treating patients with underlying medical conditions that
might be compromised by increases in blood pressure or heart rate, such as
those with pre-existing hypertension, heart failure, recent myocardial
infarction or ventricular arrhythmia. Before initiating treatment, patients
should have careful history and physical exam to assess for presence of
cardiac disease.
Use with caution in psychosis or bipolar disorder. Discontinuation of
treatment may be appropriate in the presence of treatment-emergent
psychotic or manic symptoms. While aggressive behavior is often observed in
children or adolescents with ADHD, patients beginning treatment should be
monitored for the appearance of or worsening of aggressive behavior or
hostility.
Suppression of growth has been reported with long-term use of
stimulants. Stimulants should be used with caution in patients with a prior
history of seizures or EEG abnormalities. Difficulties with accommodation
and blurring of vision have been reported with stimulant treatment. (See
WARNINGS.)
Focalin XR should be given cautiously to patients with a history of
drug dependence or alcoholism. Chronic abusive use can lead to marked
tolerance and psychological dependence with varying degrees of abnormal
behavior. Frank psychotic episodes can occur, especially with parenteral
abuse. Careful supervision is required during drug withdrawal from abusive
use since severe depression may occur. Withdrawal following chronic
therapeutic use may unmask symptoms of the underlying disorder that may
require follow-up.
For further information, please visit FocalinXR.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "suggests," "can," "is seeking," "may,"
or similar expressions, or by express or implied discussions regarding
potential additional labeling or indications or potential future sales of
Focalin XR. Such forward-looking statements reflect the current views of
Novartis regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results to be
materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that
Focalin XR will be approved for any additional labeling or indications in
any country. Nor can there be any guarantee that Focalin XR will reach any
particular sales levels. In particular, management's expectations regarding
Focalin XR could be affected by, among other things, unexpected regulatory
actions or delays or government regulation generally; unexpected clinical
trial results, including unexpected new clinical data, and unexpected
additional analysis of existing clinical data; the company's ability to
obtain or maintain patent or other proprietary intellectual property
protection; competition in general; increased government, industry, and
general public pricing pressures; and other risks and factors referred to
in Novartis AG's current Form 20-F on file with the U.S. Securities and
Exchange Commission. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual
results may vary materially from those anticipated, believed, estimated or
expected. Novartis is providing the information in this press release as of
this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a result of
new information, future events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system, dermatological, GI
and respiratory areas. The company's mission is to improve people's lives
by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS), which provides
healthcare solutions that address the evolving needs of patients and
societies. Focused solely on growth areas in healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines and diagnostic
tools, and consumer health products. Novartis is the only company with
leading positions in these areas. In 2007, the Group's continuing
operations (excluding divestments in 2007) achieved net sales of USD 38.1
billion and net income of USD 6.5 billion. Approximately USD 6.4 billion
was invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately 98,000
full-time associates and operate in over 140 countries around the world.
For more information, please visit novartis.
Novartis Partnerships
Celgene Corporation (Nasdaq: CELG) of Summit, New Jersey granted
Novartis Pharma AG an exclusive worldwide (excluding Canada) license
covering its intellectual property rights associated with Focalin XR.
Pursuant to an agreement between Novartis Pharma AG and Novartis
Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation markets
Focalin XR in the U.S.
Focalin XR was developed with SODAS(R) technology (spheroidal oral drug
absorption system), a multiparticulate drug delivery system of Elan
Corporation, plc (NYSE: ELN). Focalin XR is being supplied to Novartis
under an exclusive worldwide (except Canada) royalty and manufacturing
agreement between Elan Corporation, plc, and Novartis Pharma AG.
References
1. Concerta(R) is a registered trademark of ALZA Corporation.
2. The 30 mg dose of Focalin XR is not an FDA-approved dosage strength.
Novartis Pharmaceuticals Corporation
novartis
View drug information on Concerta; Focalin.
воскресенье, 19 июня 2011 г.
суббота, 18 июня 2011 г.
In ADHD The Brain Matures A Few Years Late But Follows Normal Pattern
In youth with attention deficit hyperactivity disorder (ADHD), the brain matures in a normal pattern but is delayed three years in some regions, on average, compared to youth without the disorder, an imaging study by researchers at the National Institutes of Health's (NIH) National Institute of Mental Health (NIMH) has revealed. The delay in ADHD was most prominent in regions at the front of the brain's outer mantle (cortex), important for the ability to control thinking, attention and planning. Otherwise, both groups showed a similar back-to-front wave of brain maturation with different areas peaking in thickness at different times.
"Finding a normal pattern of cortex maturation, albeit delayed, in children with ADHD should be reassuring to families and could help to explain why many youth eventually seem to grow out of the disorder," explained Philip Shaw, M.D., NIMH Child Psychiatry Branch, who led research team.
Previous brain imaging studies failed to detect the developmental lag because they focused on the size of the relatively large lobes of the brain. The sharp differences emerged only after a new image analysis technique allowed the researchers to pinpoint the thickening and thinning of thousands of cortex sites in hundreds of children and teens, with and without the disorder.
"If you're just looking at the lobes, you have only four measures instead of 40,000," explained Shaw. "You don't pick up the focal, regional changes where this delay is most marked."
Among 223 youth with ADHD, half of 40,000 cortex sites attained peak thickness at an average age of 10.5, compared to age 7.5 in a matched group of youth without the disorder.
Shaw, Judith Rapoport, M.D., of the NIMH Child Psychiatry Branch, Alan Evans, M.D., of McGill University, and colleagues report on their magnetic resonance imaging (MRI) study during the week of November 12, 2007, in the online edition of the Proceedings of the National Academy of Sciences.
The researchers scanned most of the 446 participants -- ranging from preschoolers to young adults -- at least twice at about three-year intervals. They focused on the age when cortex thickening during childhood gives way to thinning following puberty, as unused neural connections are pruned for optimal efficiency during the teen years.
In both ADHD and control groups, sensory processing and motor control areas at the back and top of the brain peaked in thickness earlier in childhood, while the frontal cortex areas responsible for higher-order executive control functions peaked later, during the teen years. These frontal areas support the ability to suppress inappropriate actions and thoughts, focus attention, remember things from moment to moment, work for reward, and control movement -- functions often disturbed in people with ADHD.
Circuitry in the frontal and temporal (at the side of the brain) areas that integrate information from the sensory areas with the higher-order functions showed the greatest maturational delay in youth with ADHD. For example, one of the last areas to mature, the middle of the prefrontal cortex, lagged five years in those with the disorder.
The motor cortex emerged as the only area that matured faster than normal in the youth with ADHD, in contrast to the late-maturing frontal cortex areas that direct it. This mismatch might account for the restlessness and fidgety symptoms common among those with the disorder, the researchers suggested.
They also noted that the delayed pattern of maturation observed in ADHD is the opposite of that seen in other developmental brain disorders like autism, in which the volume of brain structures peak at a much earlier-than-normal age.
The findings support the theory that ADHD results from a delay in cortex maturation. In future studies, the researchers hope to find genetic underpinnings of the delay and ways of boosting processes of recovery from the disorder.
"Brain imaging is still not ready for use as a diagnostic tool in ADHD," noted Shaw. "Although the delay in cortex development was marked, it could only be detected when a very large number of children with the disorder were included. It is not yet possible to detect such delay from the brain scans of just one individual. The diagnosis of ADHD remains clinical, based on taking a history from the child, the family and teachers."
Also participating in the research were: Kristen Eskstrand, Wendy Sharp, Jonathan Blumenthal, Dede Greenstein, Liv Clasen, and Jay Giedd, M.D., NIMH.
The National Institute of Mental Health (NIMH) mission is to reduce the burden of mental and behavioral disorders through research on mind, brain, and behavior. More information is available at the NIMH website, nimh.nih.gov/.
The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nih.gov/.
Source: Jules Asher
NIH/National Institute of Mental Health
"Finding a normal pattern of cortex maturation, albeit delayed, in children with ADHD should be reassuring to families and could help to explain why many youth eventually seem to grow out of the disorder," explained Philip Shaw, M.D., NIMH Child Psychiatry Branch, who led research team.
Previous brain imaging studies failed to detect the developmental lag because they focused on the size of the relatively large lobes of the brain. The sharp differences emerged only after a new image analysis technique allowed the researchers to pinpoint the thickening and thinning of thousands of cortex sites in hundreds of children and teens, with and without the disorder.
"If you're just looking at the lobes, you have only four measures instead of 40,000," explained Shaw. "You don't pick up the focal, regional changes where this delay is most marked."
Among 223 youth with ADHD, half of 40,000 cortex sites attained peak thickness at an average age of 10.5, compared to age 7.5 in a matched group of youth without the disorder.
Shaw, Judith Rapoport, M.D., of the NIMH Child Psychiatry Branch, Alan Evans, M.D., of McGill University, and colleagues report on their magnetic resonance imaging (MRI) study during the week of November 12, 2007, in the online edition of the Proceedings of the National Academy of Sciences.
The researchers scanned most of the 446 participants -- ranging from preschoolers to young adults -- at least twice at about three-year intervals. They focused on the age when cortex thickening during childhood gives way to thinning following puberty, as unused neural connections are pruned for optimal efficiency during the teen years.
In both ADHD and control groups, sensory processing and motor control areas at the back and top of the brain peaked in thickness earlier in childhood, while the frontal cortex areas responsible for higher-order executive control functions peaked later, during the teen years. These frontal areas support the ability to suppress inappropriate actions and thoughts, focus attention, remember things from moment to moment, work for reward, and control movement -- functions often disturbed in people with ADHD.
Circuitry in the frontal and temporal (at the side of the brain) areas that integrate information from the sensory areas with the higher-order functions showed the greatest maturational delay in youth with ADHD. For example, one of the last areas to mature, the middle of the prefrontal cortex, lagged five years in those with the disorder.
The motor cortex emerged as the only area that matured faster than normal in the youth with ADHD, in contrast to the late-maturing frontal cortex areas that direct it. This mismatch might account for the restlessness and fidgety symptoms common among those with the disorder, the researchers suggested.
They also noted that the delayed pattern of maturation observed in ADHD is the opposite of that seen in other developmental brain disorders like autism, in which the volume of brain structures peak at a much earlier-than-normal age.
The findings support the theory that ADHD results from a delay in cortex maturation. In future studies, the researchers hope to find genetic underpinnings of the delay and ways of boosting processes of recovery from the disorder.
"Brain imaging is still not ready for use as a diagnostic tool in ADHD," noted Shaw. "Although the delay in cortex development was marked, it could only be detected when a very large number of children with the disorder were included. It is not yet possible to detect such delay from the brain scans of just one individual. The diagnosis of ADHD remains clinical, based on taking a history from the child, the family and teachers."
Also participating in the research were: Kristen Eskstrand, Wendy Sharp, Jonathan Blumenthal, Dede Greenstein, Liv Clasen, and Jay Giedd, M.D., NIMH.
The National Institute of Mental Health (NIMH) mission is to reduce the burden of mental and behavioral disorders through research on mind, brain, and behavior. More information is available at the NIMH website, nimh.nih.gov/.
The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nih.gov/.
Source: Jules Asher
NIH/National Institute of Mental Health
пятница, 17 июня 2011 г.
Positive study results for methylphenidate transdermal system
Shire announced at the US Psychiatric and Mental Health Congress in Las Vegas, Nevada, that its investigational methylphenidate transdermal system (MTS) demonstrated statistically significant reductions in the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) and was generally well tolerated in patients aged 6 to 12 in two clinical trials.
"Children who have ADHD must cope with symptoms throughout the day and in a number of environments, including in the classroom, during extra-curricular activities, or while at home," explained Frank Lopez, MD, developmental pediatrician at the Children's Developmental Center, Maitland, Florida. "While oral methylphenidate has long been a first-line treatment for patients with ADHD symptoms, if approved, this transdermal patch formulation would provide parents and health care professionals the first and only non-oral medication for children with ADHD."
The MTS patch was developed by Noven Pharmaceuticals, Inc. and combines the active ingredient of methylphenidate with transdermal technology. This transdermal delivery?Noven's patented DOT Matrix system was designed to provide continuous medication release throughout the day. The transdermal system releases medication that passes through the skin and directly into the blood stream. The patch is water-resistant.
Data from phase II and phase III clinical trials presented this week in Las Vegas demonstrated statistically significant improvements in the primary and secondary endpoints analyzed for children treated with MTS compared to children treated with placebo.
The phase II analog classroom study included 79 children with ADHD. The patch was worn for nine hours, and efficacy was assessed throughout the day for twelve hours. MTS demonstrated statistically significant improvement over placebo on the measures tested. Behavior, which was measured using the Swanson, Kotkin, Agler, M-Flynn, and Pelham -Deportment (SKAMP-D) scale, was improved with MTS overall (mean score 3.2 for MTS versus 8.0 for placebo) and at all time points throughout the day (P < 0.001).
Children taking MTS also completed more math problems correctly on the Permanent Product Measure of Performance (PERMP) scale than did those taking placebo (110 versus 81, respectively).
In the phase III naturalistic trial with 270 participants, investigators found that MTS worn for nine hours reduced the children's overall symptoms of ADHD, compared to a placebo (P < 0.0001), as measured by scores on the ADHD Rating Scale (ADHD-RS). By the study's end, mean ADHD-RS scores declined -24.2 points (56%) from baseline for children treated with MTS versus a decline of -9.9 (24%) for those treated with placebo (P < 0.0001). ADHD-RS assesses 18 individual symptoms of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(TM), a publication of the American Psychiatric Association.
In both studies, MTS was generally well tolerated during both the dose optimization and double-blind phases. Adverse events typically were mild to moderate, resolved with continued therapy and were consistent with known effects of methylphenidate. The most common adverse events reported by patients who received MTS in clinical trials were: nausea, vomiting, nasopharyngitis, weight decreased, anorexia, decreased appetite, affect lability, insomnia, tic, and nasal congestion.
Shire and Noven provided funds for both studies.
Noven and Shire are seeking approval for MTS and the application is currently under review by the FDA. The trade name DAYTRANA(TM) has been proposed to the FDA and is currently under review.
About MTS
MTS is not intended to be administered to patients with: marked anxiety, tension or agitation; allergies to methylphenidate or other ingredients in MTS; skin sensitivities to soaps, lotions, cosmetics or adhesives; eczema, psoriasis, dermatitis or sensitive skin syndrome. MTS has not been studied in children under 6 years of age. Patients will be advised to avoid direct external heat to the patch application site. MTS will need to be stored in a safe place, out of the reach of children.
Methylphenidate should not be administered to patients with:
glaucoma; tics, Tourette's syndrome or a family history of Tourette's syndrome; current or recent use of Monoamine Oxidase Inhibitors (MAOIs). Chronic abuse of methylphenidate may lead to dependence and careful supervision following withdrawal from abuse is warranted. Methylphenidate should not be given to patients with a history of drug dependence or alcoholism. Methylphenidate should not be used for the prevention or treatment of severe depression or normal fatigue states. Growth should be monitored in patients treated with methylphenidate. Use with caution in patients with psychosis, history of seizures or EEG abnormalities, hypertension, and history of drug dependence or alcoholism. Rare cases of visual disturbances have been reported with methylphenidate use. Hematologic monitoring is advised during prolonged therapy.
About ADHD
ADHD affects approximately 7.8 percent of all school-age children, more than 4 million in the United States. ADHD is considered the most commonly diagnosed psychiatric disorder in children and adolescents. ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable age and maturity. If untreated, ADHD can acutely affect a child's life, leading to problems with family members, friends, sports, after-school activities and academics.
Shire Pharmaceuticals Group plc
Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on central nervous system (CNS), gastrointestinal (GI), general products (GP) and human genetic therapies (HGT) - all being areas in which Shire has a commercial presence. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. This approach aims to deliver increased returns and lower risks. Shire's in-licensing and merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company's website: shire
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to, the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise; patents, including, but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including, but not limited to, the expected product approval dates of DAYTRANA (MTS/METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), MESAVANCE (SPD476) (ulcerative colitis), I2S (iduronate-2-sulfatase) (Hunter syndrome), and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire's ability to benefit from its acquisition of Transkaryotic Therapies, Inc.; Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year to December 31, 2004.
A high-resolution image is available at: hispanicprwire/home.php?l=in
Matthew Cabrey
484-595-8248B
Media Relations
Brian Piper
484-595-8252
Investor Relations
Shire Pharmaceuticals Group
shire/shire/index.jsp
"Children who have ADHD must cope with symptoms throughout the day and in a number of environments, including in the classroom, during extra-curricular activities, or while at home," explained Frank Lopez, MD, developmental pediatrician at the Children's Developmental Center, Maitland, Florida. "While oral methylphenidate has long been a first-line treatment for patients with ADHD symptoms, if approved, this transdermal patch formulation would provide parents and health care professionals the first and only non-oral medication for children with ADHD."
The MTS patch was developed by Noven Pharmaceuticals, Inc. and combines the active ingredient of methylphenidate with transdermal technology. This transdermal delivery?Noven's patented DOT Matrix system was designed to provide continuous medication release throughout the day. The transdermal system releases medication that passes through the skin and directly into the blood stream. The patch is water-resistant.
Data from phase II and phase III clinical trials presented this week in Las Vegas demonstrated statistically significant improvements in the primary and secondary endpoints analyzed for children treated with MTS compared to children treated with placebo.
The phase II analog classroom study included 79 children with ADHD. The patch was worn for nine hours, and efficacy was assessed throughout the day for twelve hours. MTS demonstrated statistically significant improvement over placebo on the measures tested. Behavior, which was measured using the Swanson, Kotkin, Agler, M-Flynn, and Pelham -Deportment (SKAMP-D) scale, was improved with MTS overall (mean score 3.2 for MTS versus 8.0 for placebo) and at all time points throughout the day (P < 0.001).
Children taking MTS also completed more math problems correctly on the Permanent Product Measure of Performance (PERMP) scale than did those taking placebo (110 versus 81, respectively).
In the phase III naturalistic trial with 270 participants, investigators found that MTS worn for nine hours reduced the children's overall symptoms of ADHD, compared to a placebo (P < 0.0001), as measured by scores on the ADHD Rating Scale (ADHD-RS). By the study's end, mean ADHD-RS scores declined -24.2 points (56%) from baseline for children treated with MTS versus a decline of -9.9 (24%) for those treated with placebo (P < 0.0001). ADHD-RS assesses 18 individual symptoms of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(TM), a publication of the American Psychiatric Association.
In both studies, MTS was generally well tolerated during both the dose optimization and double-blind phases. Adverse events typically were mild to moderate, resolved with continued therapy and were consistent with known effects of methylphenidate. The most common adverse events reported by patients who received MTS in clinical trials were: nausea, vomiting, nasopharyngitis, weight decreased, anorexia, decreased appetite, affect lability, insomnia, tic, and nasal congestion.
Shire and Noven provided funds for both studies.
Noven and Shire are seeking approval for MTS and the application is currently under review by the FDA. The trade name DAYTRANA(TM) has been proposed to the FDA and is currently under review.
About MTS
MTS is not intended to be administered to patients with: marked anxiety, tension or agitation; allergies to methylphenidate or other ingredients in MTS; skin sensitivities to soaps, lotions, cosmetics or adhesives; eczema, psoriasis, dermatitis or sensitive skin syndrome. MTS has not been studied in children under 6 years of age. Patients will be advised to avoid direct external heat to the patch application site. MTS will need to be stored in a safe place, out of the reach of children.
Methylphenidate should not be administered to patients with:
glaucoma; tics, Tourette's syndrome or a family history of Tourette's syndrome; current or recent use of Monoamine Oxidase Inhibitors (MAOIs). Chronic abuse of methylphenidate may lead to dependence and careful supervision following withdrawal from abuse is warranted. Methylphenidate should not be given to patients with a history of drug dependence or alcoholism. Methylphenidate should not be used for the prevention or treatment of severe depression or normal fatigue states. Growth should be monitored in patients treated with methylphenidate. Use with caution in patients with psychosis, history of seizures or EEG abnormalities, hypertension, and history of drug dependence or alcoholism. Rare cases of visual disturbances have been reported with methylphenidate use. Hematologic monitoring is advised during prolonged therapy.
About ADHD
ADHD affects approximately 7.8 percent of all school-age children, more than 4 million in the United States. ADHD is considered the most commonly diagnosed psychiatric disorder in children and adolescents. ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable age and maturity. If untreated, ADHD can acutely affect a child's life, leading to problems with family members, friends, sports, after-school activities and academics.
Shire Pharmaceuticals Group plc
Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on central nervous system (CNS), gastrointestinal (GI), general products (GP) and human genetic therapies (HGT) - all being areas in which Shire has a commercial presence. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. This approach aims to deliver increased returns and lower risks. Shire's in-licensing and merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company's website: shire
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to, the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise; patents, including, but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including, but not limited to, the expected product approval dates of DAYTRANA (MTS/METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), MESAVANCE (SPD476) (ulcerative colitis), I2S (iduronate-2-sulfatase) (Hunter syndrome), and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire's ability to benefit from its acquisition of Transkaryotic Therapies, Inc.; Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year to December 31, 2004.
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Matthew Cabrey
484-595-8248B
Media Relations
Brian Piper
484-595-8252
Investor Relations
Shire Pharmaceuticals Group
shire/shire/index.jsp
четверг, 16 июня 2011 г.
Is There A Gender Difference Related To Movement In ADHD
Attention deficit hyperactivity disorder (ADHD) appears to affect movement in boys more than it does in girls, according to a study published in the November 4, 2008, issue of Neurology®, the medical journal of the American Academy of Neurology. ADHD is one of the most common mental disorders found in children. Symptoms include impulsiveness, hyperactivity, such as not being able to sit still, and inattention or constant daydreaming. Few studies have been done that compare ADHD and movement in both boys and girls.
Researchers tested the movement abilities of 132 boys and girls with ADHD and 136 without the disorder. The children were between the ages of seven and 15 years and were tested for how fast and how well they could tap their toes, walk on their heels, maintain balance and keep a steady rhythm during a task compared to scores typical for their age.
The study found that girls with ADHD and the control group of children without ADHD were twice as likely to be able to control their movements for their age compared to boys with ADHD, who showed continued difficulties.
"Our findings suggest that the differences between boys and girls with ADHD show up not only in behavior and symptoms but also in development of movement control, likely because girls' brains mature earlier than boys' brains," said study author E. Mark Mahone, PhD, with the Kennedy Krieger Institute and Johns Hopkins University School of Medicine in Baltimore, MD.
"More studies related to ADHD and movement are needed that look at boys and girls separately and at younger ages," said Mahone.
The study was supported by the National Institute of Neurological Disorders and Stroke, Kennedy Krieger Institute's Developmental Disabilities Research Center and the Johns Hopkins University School of Medicine Institute for Clinical and Translational Research.
The American Academy of Neurology, an association of more than 21,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as stroke, Alzheimer's disease, epilepsy, Parkinson's disease, and multiple sclerosis.
For more information about the American Academy of Neurology, visit http:/aan/.
Source: Rachel Seroka
American Academy of Neurology
Researchers tested the movement abilities of 132 boys and girls with ADHD and 136 without the disorder. The children were between the ages of seven and 15 years and were tested for how fast and how well they could tap their toes, walk on their heels, maintain balance and keep a steady rhythm during a task compared to scores typical for their age.
The study found that girls with ADHD and the control group of children without ADHD were twice as likely to be able to control their movements for their age compared to boys with ADHD, who showed continued difficulties.
"Our findings suggest that the differences between boys and girls with ADHD show up not only in behavior and symptoms but also in development of movement control, likely because girls' brains mature earlier than boys' brains," said study author E. Mark Mahone, PhD, with the Kennedy Krieger Institute and Johns Hopkins University School of Medicine in Baltimore, MD.
"More studies related to ADHD and movement are needed that look at boys and girls separately and at younger ages," said Mahone.
The study was supported by the National Institute of Neurological Disorders and Stroke, Kennedy Krieger Institute's Developmental Disabilities Research Center and the Johns Hopkins University School of Medicine Institute for Clinical and Translational Research.
The American Academy of Neurology, an association of more than 21,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as stroke, Alzheimer's disease, epilepsy, Parkinson's disease, and multiple sclerosis.
For more information about the American Academy of Neurology, visit http:/aan/.
Source: Rachel Seroka
American Academy of Neurology
среда, 15 июня 2011 г.
Vaccinated Children Two And A Half Times More Likely To Have Neurological Disorders Like ADHD And Autism, New Survey In California And Oregon Finds
As the first trial
in Vaccine Court explores the relationship between vaccines and autism, a
new survey released today indicates a strong correlation between rates of
neurological disorders, such as ADHD and autism, and childhood
vaccinations.
The survey, commissioned by Generation Rescue, compared vaccinated and
unvaccinated children in nine counties in Oregon and California. Among more
than 9,000 boys age 4-17, the survey found vaccinated boys were two and a
half times (155%) more likely to have neurological disorders compared to
their unvaccinated peers. Vaccinated boys were 224% more likely to have
Attention Deficit Hyperactivity Disorder (ADHD), and 61% more likely to
have autism.
For older vaccinated boys in the 11-17 age bracket, the results were
even more pronounced. Vaccinated boys were 158% more likely to have a
neurological disorder, 317% more likely to have ADHD, and 112% more likely
to have autism. Complete survey results are available at
GenerationRescue.
Generation Rescue commissioned the phone survey. Data was gathered by
SurveyUSA, a national market research firm, which surveyed parents by phone
on more than 17,000 children, ages 4-17, in five counties in California
(San Diego, Sonoma, Orange, Sacramento, and Marin) and four counties in
Oregon (Multnomah, Marion, Jackson, and Lane).
The survey asked parents whether their child had been vaccinated, and
whether that child had one or more of the following diagnoses: Attention
Deficit Disorder (ADD), ADHD, Asperger's Syndrome, Pervasive Development
Disorder -- Not Otherwise Specified (PDD-NOS), or Autism. The phone survey
was chosen to mirror the methodology the Centers for Disease Control (CDC)
uses to establish national prevalence for neurological disorders in their
national phone survey.
Timed to the release of the survey results, Generation Rescue also ran
full-page advertisements in Washington's Roll Call, The Oregonian, and The
Orange County Register today. The ad compares the 36 pediatric vaccines the
CDC recommends today to the 10 recommended in 1983, and asks, "Are We Over-
Vaccinating Our Kids?"
"No one has ever compared prevalence rates of these neurological
disorders between vaccinated and unvaccinated children," said J.B. Handley,
co-founder of Generation Rescue, whose son was diagnosed with autism. "The
phone survey isn't perfect, but these numbers point to the need for a
comprehensive national study to gather this critical information."
In Washington, Congresswoman Carolyn Maloney (D-NY) has been advocating
for such a survey. Co-sponsored by Rep. Maurice Hinchey (D-NY) and Rep. Ron
Paul (R-TX), the "Comprehensive Comparative Study of Vaccinated and
Unvaccinated Population Act of 2006," or H.R. 2832, was introduced on June
22, and would require the National Institutes of Health to complete this
research.
"Generation Rescue's study is impressive and forcefully raises some
serious questions about the relationship between vaccines and autism. What
is ultimately needed to resolve this issue one way or the other is a
comprehensive national study of vaccinated and unvaccinated children," said
Congresswoman Maloney. "The parents behind Generation Rescue only want
information. These parents deserve more than road blocks, they deserve
answers. We can and should move forward in search of those answers. That's
why I've introduced a common sense bill that would require the National
Institutes of Health (NIH) to conduct a comprehensive, comparative study on
the possible link between autism and thimerosal."
From 1983 to 2007, autism rates have climbed from 1 in 10,000 children
to 1 in 150 children, a growth rate of 6,000% (boys are significantly more
affected by neurological disorders, accounting for approximately 80% of all
cases). ADHD currently affects 1 in 13 children. In the same period, the
CDC's recommended vaccine schedule more than tripled. The simmering debate
over the cause of childhood neurological disorders shows no sign of
cooling, but no study had ever been done to look at unvaccinated children.
Lisa Handley, co-founder of Generation Rescue, adds, "Everyone working
with autism wants to identify the cause so we can focus on treatment and
prevention. A national study like HR 5940 could help end this debate and
focus all of our resources on helping our kids. Its time has come, and we
hope Congress will choose to put our children first."
About Generation Rescue
Generation Rescue was formed by parents of children who have been
diagnosed with childhood neurological disorders (NDs), and is dedicated to
examining the causes and biomedical treatments for Autism, Asperger's,
ADHD, ADD, PDD-NOS, and other learning disabilities. Visit
GenerationRescue for more information and to see complete survey
results.
Generation Rescue
GenerationRescue
in Vaccine Court explores the relationship between vaccines and autism, a
new survey released today indicates a strong correlation between rates of
neurological disorders, such as ADHD and autism, and childhood
vaccinations.
The survey, commissioned by Generation Rescue, compared vaccinated and
unvaccinated children in nine counties in Oregon and California. Among more
than 9,000 boys age 4-17, the survey found vaccinated boys were two and a
half times (155%) more likely to have neurological disorders compared to
their unvaccinated peers. Vaccinated boys were 224% more likely to have
Attention Deficit Hyperactivity Disorder (ADHD), and 61% more likely to
have autism.
For older vaccinated boys in the 11-17 age bracket, the results were
even more pronounced. Vaccinated boys were 158% more likely to have a
neurological disorder, 317% more likely to have ADHD, and 112% more likely
to have autism. Complete survey results are available at
GenerationRescue.
Generation Rescue commissioned the phone survey. Data was gathered by
SurveyUSA, a national market research firm, which surveyed parents by phone
on more than 17,000 children, ages 4-17, in five counties in California
(San Diego, Sonoma, Orange, Sacramento, and Marin) and four counties in
Oregon (Multnomah, Marion, Jackson, and Lane).
The survey asked parents whether their child had been vaccinated, and
whether that child had one or more of the following diagnoses: Attention
Deficit Disorder (ADD), ADHD, Asperger's Syndrome, Pervasive Development
Disorder -- Not Otherwise Specified (PDD-NOS), or Autism. The phone survey
was chosen to mirror the methodology the Centers for Disease Control (CDC)
uses to establish national prevalence for neurological disorders in their
national phone survey.
Timed to the release of the survey results, Generation Rescue also ran
full-page advertisements in Washington's Roll Call, The Oregonian, and The
Orange County Register today. The ad compares the 36 pediatric vaccines the
CDC recommends today to the 10 recommended in 1983, and asks, "Are We Over-
Vaccinating Our Kids?"
"No one has ever compared prevalence rates of these neurological
disorders between vaccinated and unvaccinated children," said J.B. Handley,
co-founder of Generation Rescue, whose son was diagnosed with autism. "The
phone survey isn't perfect, but these numbers point to the need for a
comprehensive national study to gather this critical information."
In Washington, Congresswoman Carolyn Maloney (D-NY) has been advocating
for such a survey. Co-sponsored by Rep. Maurice Hinchey (D-NY) and Rep. Ron
Paul (R-TX), the "Comprehensive Comparative Study of Vaccinated and
Unvaccinated Population Act of 2006," or H.R. 2832, was introduced on June
22, and would require the National Institutes of Health to complete this
research.
"Generation Rescue's study is impressive and forcefully raises some
serious questions about the relationship between vaccines and autism. What
is ultimately needed to resolve this issue one way or the other is a
comprehensive national study of vaccinated and unvaccinated children," said
Congresswoman Maloney. "The parents behind Generation Rescue only want
information. These parents deserve more than road blocks, they deserve
answers. We can and should move forward in search of those answers. That's
why I've introduced a common sense bill that would require the National
Institutes of Health (NIH) to conduct a comprehensive, comparative study on
the possible link between autism and thimerosal."
From 1983 to 2007, autism rates have climbed from 1 in 10,000 children
to 1 in 150 children, a growth rate of 6,000% (boys are significantly more
affected by neurological disorders, accounting for approximately 80% of all
cases). ADHD currently affects 1 in 13 children. In the same period, the
CDC's recommended vaccine schedule more than tripled. The simmering debate
over the cause of childhood neurological disorders shows no sign of
cooling, but no study had ever been done to look at unvaccinated children.
Lisa Handley, co-founder of Generation Rescue, adds, "Everyone working
with autism wants to identify the cause so we can focus on treatment and
prevention. A national study like HR 5940 could help end this debate and
focus all of our resources on helping our kids. Its time has come, and we
hope Congress will choose to put our children first."
About Generation Rescue
Generation Rescue was formed by parents of children who have been
diagnosed with childhood neurological disorders (NDs), and is dedicated to
examining the causes and biomedical treatments for Autism, Asperger's,
ADHD, ADD, PDD-NOS, and other learning disabilities. Visit
GenerationRescue for more information and to see complete survey
results.
Generation Rescue
GenerationRescue
вторник, 14 июня 2011 г.
ADHD - Important Strattera(R) Label Update Regarding Uncommon Reports of Suicidal Thoughts Among Children and Adolescents
Eli Lilly and Company announced that it will update the product label globally for
its attention-deficit/hyperactivity disorder (ADHD) medication, Strattera, to
communicate new information regarding uncommon reports of suicidal thoughts
among children and adolescents.
In conjunction with a request from the U.S.
Food and Drug Administration (FDA), Lilly submitted to regulatory agencies an
analysis of adverse event data from its Strattera clinical trials database
that identified a small but statistically significant increased risk of
suicidal thoughts among Strattera-treated children and adolescents (5 cases
out of 1357 patients or 0.4 percent vs. 0 cases out of 851 patients taking
placebo).
There also was one case of a suicide attempt in a patient taking
the medication (out of 1357 patients). There were no suicides among children,
adolescents or adults on the medication during any Strattera clinical trials,
and there was no indication of an increased risk of suicidal thinking in the
adult population. As part of the FDA's continuing focus on patient safety,
the agency and its Pediatric Advisory Committee plan to complete an ongoing
review of adverse event data for all ADHD medications by early 2006.
In the United States, Lilly will add a boxed warning to the product label
and is working with the FDA to finalize the product label content as well as
information for healthcare professionals. Lilly is also working with other
regulatory agencies where the product is currently approved regarding this
safety information. In Europe, the information will be provided under the
special warnings and precautions section of the product label. In Australia,
it will appear as a precaution.
"Lilly's top priority is to help doctors, patients and their families make
informed treatment decisions, so we are reaching out extensively to educate
physicians and the public about this product label change," said Alan Breier,
M.D., vice president and chief medical officer at Lilly. "While suicidal
thinking was uncommon in patients on the medication during clinical trials, it
is important for parents to be aware it can occur, and to discuss any unusual
symptoms with a physician. Also important for parents to know," he said, "is
that Lilly continues to view Strattera as a safe and effective treatment
option, and those doing well on the medication should be able to continue
their treatment with confidence."
Investor Information
Lilly is confirming its prior sales and earnings guidance for the year.
Lilly expects reported full-year 2005 earnings per share of $1.90 to $1.96.
Eliminating the second-quarter 2005 product liability charge of $.90 per
share, the adjusted full-year 2005 earnings per share would be $2.80 to $2.86.
For the full year of 2005, the company continues to expect sales growth of
6 to 8 percent.
ADHD and Suicide
ADHD affects 3-7 percent of school-age children and manifests itself in
levels of attention, concentration, activity, distractibility and impulsivity
that are inappropriate to the child's age.(1) ADHD is a serious disorder that
can have lifelong consequences, including poor peer relations, poor academic
and work performance and increased risk-taking behaviors such as substance
abuse.(2,3,4) Sixty percent of children with the disorder carry their
symptoms into adulthood.(5) Experts estimate 4 percent of adults in the
United States, more than 8 million people, have ADHD.(6,7)
"ADHD is a complex disorder and many patients who are managing it are
often dealing with other co-existing psychiatric disorders," said Christopher
Kratochvil, M.D., associate professor of psychiatry at the University of
Nebraska Medical Center. "As a physician, I believe strong communication
between the doctor, parents, caregivers and patients is vital to successful
mental health treatment."
The FDA's request for clinical trial data is part of the agency's ongoing
review of psychiatric medicines, reflecting the scientific community's growing
understanding of suicide-related behaviors and how to analyze them. The
analysis was based on criteria developed by Columbia University and the FDA
last year, and uses a rigorous classification system to assess any risk of
suicide-related events in clinical trials.
According to the World Health Organization, suicidal thoughts or behaviors
have a large number of complex, underlying causes that can make it difficult
to determine why some people experience these feelings. Suicidal thoughts
occur in children and adolescents and are not always associated with other
features of mental illness. There is evidence that those suffering from ADHD
are at greater risk of suicide than the general population.(8,9)
Information for Patients and Physicians
Lilly is working in concert with regulatory agencies worldwide to notify
physicians about this important update. In addition, the company is notifying
consumer advocacy and professionally focused associations about these findings
so they can provide important information to patients. In the U.S., Lilly's
outreach efforts will include a "Dear Healthcare Professional" letter, sales
force communications to prescribers and updated label information on the
product web site, strattera.
All medications have side effects. No medication works for everyone. As
with any medication, patients or parents should consult their doctors with any
questions or concerns regarding treatment. This allows physicians and
patients to make the most informed treatment decisions. Patients or
caregivers with questions may also call the Lilly Answers Center at
1-800-LillyRx.
About Strattera
Strattera, a selective norepinephrine reuptake inhibitor, is the first
FDA-approved non-stimulant to treat ADHD and provide full-symptom relief. It
is not known precisely how Strattera reduces ADHD symptoms, but scientists
believe it works by blocking or slowing reabsorption of norepinephrine, a
chemical in the brain considered important in regulating attention,
impulsivity and activity levels. This keeps more norepinephrine at work in
the spaces between neurons in the brain. Improved efficiency in the
norepinephrine system is associated with improvement in symptoms of ADHD
(Pliska, 1996).
Strattera should not be taken at the same time as, or within two weeks of
taking, a monoamine oxidase inhibitor (MAOI) or by patients with narrow angle
glaucoma. Patients with a history of high or low blood pressure, increased
heart rate, or any heart or blood vessel disease should tell their doctor
before taking Strattera. Strattera has not been tested in children less than
6 years of age or in geriatric patients. Some children may lose weight when
starting treatment with Strattera. As with all ADHD medications, growth
should be monitored during treatment. Strattera can cause liver damage in
rare cases. Patients should tell their doctor right away if they have
itching, dark urine, yellow skin/eyes, upper right-sided abdominal tenderness,
or unexplained "flu-like" symptoms.
Most people in clinical studies who experienced side effects were not
bothered enough to stop using Strattera. The most common side effects in
children and adolescents in medical studies were upset stomach, decreased
appetite, nausea and vomiting, dizziness, tiredness and mood swings. In
adults, the most common side effects were constipation, dry mouth, nausea,
decreased appetite, dizziness, problems sleeping, sexual side effects,
problems urinating and menstrual cramps.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers -- through medicines and
information -- for some of the world's most urgent medical needs. Additional
information about Lilly is available at lilly.
For full prescribing information visit strattera.
This press release contains forward-looking statements about the use of
Strattera for the treatment of ADHD and reflects Lilly's current beliefs.
However, as with any pharmaceutical product, there are substantial risks and
uncertainties, including risk of side effects and other safety concerns; and
there is no guarantee regarding the future commercial success of the product.
The company's results may also be affected by such factors as competitive
developments affecting current products; rate of sales growth of recently
launched products; the timing of anticipated regulatory approvals and launches
of new products; other regulatory developments and government investigations;
patent disputes and other litigation involving current and future products;
the impact of governmental actions regarding pricing, importation, and
reimbursement for pharmaceuticals; changes in tax law; and the impact of
exchange rates. For additional information about the factors that affect the
company's business, please see Exhibit 99 to the company's latest Form 10-Q
filed August 2005. The company undertakes no duty to update forward-looking
statements.
(1) American Psychiatric Association: Diagnostic and Statistical Manual
of Mental Disorders, fourth edition, text revision, Washington, DC, American
Psychiatric Association, 2000.
(2) Greenhill LL. Diagnosing attention-deficit/hyperactivity disorder in
children. J Clin Psychiatry 1998; 59 (Suppl 7): 31-41.
(3) Faraone S, Biederman J, et al. ADHD in adults: an overview. Biol
Psychiatry 2000; 48:9-20.
(4) Barkley. ADHD: A Handbook for Diagnosis and Treatment. New York:
Guilford Press; 1998.
(5) Schweitzer JB, et al. Attention-deficit/hyperactivity disorder. Med
Clin of North Am. 2001; 85(3): 757-777
(6) Murphy K, Barkley, RA. J Atten disord. 1996; 1:147-161.
(7) United States Census Summary File; 2000.
(8) Swensen A, Kruesi M, Allen A, et al. Self injury and suicide in
patients with attention deficit hyperactivity disorder. Program and abstracts
of the American Academy of Child and Adolescent Psychiatry 49th Annual
Meeting; October 22-27, 2002; San Francisco, California. New Research F27.
(9) James A, Lai FH, Dahl C. Attention deficit hyperactivity disorder and
suicide: a review of possible associations. Acta Psychiatr Scand
2004;110:408-415.
lilly
View drug information on Strattera.
its attention-deficit/hyperactivity disorder (ADHD) medication, Strattera, to
communicate new information regarding uncommon reports of suicidal thoughts
among children and adolescents.
In conjunction with a request from the U.S.
Food and Drug Administration (FDA), Lilly submitted to regulatory agencies an
analysis of adverse event data from its Strattera clinical trials database
that identified a small but statistically significant increased risk of
suicidal thoughts among Strattera-treated children and adolescents (5 cases
out of 1357 patients or 0.4 percent vs. 0 cases out of 851 patients taking
placebo).
There also was one case of a suicide attempt in a patient taking
the medication (out of 1357 patients). There were no suicides among children,
adolescents or adults on the medication during any Strattera clinical trials,
and there was no indication of an increased risk of suicidal thinking in the
adult population. As part of the FDA's continuing focus on patient safety,
the agency and its Pediatric Advisory Committee plan to complete an ongoing
review of adverse event data for all ADHD medications by early 2006.
In the United States, Lilly will add a boxed warning to the product label
and is working with the FDA to finalize the product label content as well as
information for healthcare professionals. Lilly is also working with other
regulatory agencies where the product is currently approved regarding this
safety information. In Europe, the information will be provided under the
special warnings and precautions section of the product label. In Australia,
it will appear as a precaution.
"Lilly's top priority is to help doctors, patients and their families make
informed treatment decisions, so we are reaching out extensively to educate
physicians and the public about this product label change," said Alan Breier,
M.D., vice president and chief medical officer at Lilly. "While suicidal
thinking was uncommon in patients on the medication during clinical trials, it
is important for parents to be aware it can occur, and to discuss any unusual
symptoms with a physician. Also important for parents to know," he said, "is
that Lilly continues to view Strattera as a safe and effective treatment
option, and those doing well on the medication should be able to continue
their treatment with confidence."
Investor Information
Lilly is confirming its prior sales and earnings guidance for the year.
Lilly expects reported full-year 2005 earnings per share of $1.90 to $1.96.
Eliminating the second-quarter 2005 product liability charge of $.90 per
share, the adjusted full-year 2005 earnings per share would be $2.80 to $2.86.
For the full year of 2005, the company continues to expect sales growth of
6 to 8 percent.
ADHD and Suicide
ADHD affects 3-7 percent of school-age children and manifests itself in
levels of attention, concentration, activity, distractibility and impulsivity
that are inappropriate to the child's age.(1) ADHD is a serious disorder that
can have lifelong consequences, including poor peer relations, poor academic
and work performance and increased risk-taking behaviors such as substance
abuse.(2,3,4) Sixty percent of children with the disorder carry their
symptoms into adulthood.(5) Experts estimate 4 percent of adults in the
United States, more than 8 million people, have ADHD.(6,7)
"ADHD is a complex disorder and many patients who are managing it are
often dealing with other co-existing psychiatric disorders," said Christopher
Kratochvil, M.D., associate professor of psychiatry at the University of
Nebraska Medical Center. "As a physician, I believe strong communication
between the doctor, parents, caregivers and patients is vital to successful
mental health treatment."
The FDA's request for clinical trial data is part of the agency's ongoing
review of psychiatric medicines, reflecting the scientific community's growing
understanding of suicide-related behaviors and how to analyze them. The
analysis was based on criteria developed by Columbia University and the FDA
last year, and uses a rigorous classification system to assess any risk of
suicide-related events in clinical trials.
According to the World Health Organization, suicidal thoughts or behaviors
have a large number of complex, underlying causes that can make it difficult
to determine why some people experience these feelings. Suicidal thoughts
occur in children and adolescents and are not always associated with other
features of mental illness. There is evidence that those suffering from ADHD
are at greater risk of suicide than the general population.(8,9)
Information for Patients and Physicians
Lilly is working in concert with regulatory agencies worldwide to notify
physicians about this important update. In addition, the company is notifying
consumer advocacy and professionally focused associations about these findings
so they can provide important information to patients. In the U.S., Lilly's
outreach efforts will include a "Dear Healthcare Professional" letter, sales
force communications to prescribers and updated label information on the
product web site, strattera.
All medications have side effects. No medication works for everyone. As
with any medication, patients or parents should consult their doctors with any
questions or concerns regarding treatment. This allows physicians and
patients to make the most informed treatment decisions. Patients or
caregivers with questions may also call the Lilly Answers Center at
1-800-LillyRx.
About Strattera
Strattera, a selective norepinephrine reuptake inhibitor, is the first
FDA-approved non-stimulant to treat ADHD and provide full-symptom relief. It
is not known precisely how Strattera reduces ADHD symptoms, but scientists
believe it works by blocking or slowing reabsorption of norepinephrine, a
chemical in the brain considered important in regulating attention,
impulsivity and activity levels. This keeps more norepinephrine at work in
the spaces between neurons in the brain. Improved efficiency in the
norepinephrine system is associated with improvement in symptoms of ADHD
(Pliska, 1996).
Strattera should not be taken at the same time as, or within two weeks of
taking, a monoamine oxidase inhibitor (MAOI) or by patients with narrow angle
glaucoma. Patients with a history of high or low blood pressure, increased
heart rate, or any heart or blood vessel disease should tell their doctor
before taking Strattera. Strattera has not been tested in children less than
6 years of age or in geriatric patients. Some children may lose weight when
starting treatment with Strattera. As with all ADHD medications, growth
should be monitored during treatment. Strattera can cause liver damage in
rare cases. Patients should tell their doctor right away if they have
itching, dark urine, yellow skin/eyes, upper right-sided abdominal tenderness,
or unexplained "flu-like" symptoms.
Most people in clinical studies who experienced side effects were not
bothered enough to stop using Strattera. The most common side effects in
children and adolescents in medical studies were upset stomach, decreased
appetite, nausea and vomiting, dizziness, tiredness and mood swings. In
adults, the most common side effects were constipation, dry mouth, nausea,
decreased appetite, dizziness, problems sleeping, sexual side effects,
problems urinating and menstrual cramps.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers -- through medicines and
information -- for some of the world's most urgent medical needs. Additional
information about Lilly is available at lilly.
For full prescribing information visit strattera.
This press release contains forward-looking statements about the use of
Strattera for the treatment of ADHD and reflects Lilly's current beliefs.
However, as with any pharmaceutical product, there are substantial risks and
uncertainties, including risk of side effects and other safety concerns; and
there is no guarantee regarding the future commercial success of the product.
The company's results may also be affected by such factors as competitive
developments affecting current products; rate of sales growth of recently
launched products; the timing of anticipated regulatory approvals and launches
of new products; other regulatory developments and government investigations;
patent disputes and other litigation involving current and future products;
the impact of governmental actions regarding pricing, importation, and
reimbursement for pharmaceuticals; changes in tax law; and the impact of
exchange rates. For additional information about the factors that affect the
company's business, please see Exhibit 99 to the company's latest Form 10-Q
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statements.
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понедельник, 13 июня 2011 г.
ADHD And Sleep Problems In Adolescents Linked By Study
A study in the May 1 issue of the journal SLEEP shows that adolescents with a childhood diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) are more likely to have current and lifetime sleep problems and disorders, regardless of the severity of current ADHD symptoms. Authors suggest that findings indicate that mental health professionals should screen for sleep problems and psychiatric comorbidities among all adolescents with a childhood diagnosis of ADHD.
Results indicate that adolescents with a childhood diagnosis of ADHD, regardless of persistent ADHD were more likely to have current sleep problems and sleep disorders such as insomnia, sleep terrors, nightmares, bruxism and snoring. Of the total sample, 17 percent of children with ADHD were currently suffering from primary insomnia, versus 7 percent of controls; lifetime primary insomnia occurred in 20 percent of children with ADHD, compared to 10 percent of controls. Nightmare disorder affected 11 percent of children with ADHD and lifetime nightmare disorder affected 23 percent, versus 5 and 16 percent of controls. The presence of at least one psychiatric comorbid condition increases the risks for insomnia and nightmares.
According to principal investigator Susan Shur-Fen Gau, MD, PhD, associate professor at the College of Medicine and Public Health, National Taiwan University, symptoms and consequences of ADHD and sleep problems in children often overlap. Some primary sleep disorders are found to be associated with inattention, hyperactivity, behavioral problems and impaired academic performance, which are often mistaken for symptoms of ADHD.
"In some patients with ADHD, symptoms are caused or exaggerated by primary sleep disorders, and therefore treatment of the sleep disorder will improve ADHD symptoms," said Gau.
Data were collected from 281 consecutive patients (86.2 percent male) between the ages of 10 to 17 years who had been diagnosed with ADHD according to DSM-IV criteria at a mean age of 6.7 years, and 185 controls who did not have ADHD as a child or teen. Diagnosis of ADHD was made based on information obtained from parent and child interviews, observation of the child's behaviors, and rating scales reported by parents and teachers.
Findings of the study indicated that the rates of nightmare and lifetime nightmare disorder were more prevalent in girls and snoring was more prevalent in boys. Snoring may be more prevalent in boys due to an increased rate of sleep-disordered breathing in boys. Mothers were found to be more aware of symptoms related to ADHD in the presence of primary insomnia, sleep terror disorder or sleepwalking disorder, whereas teachers may be more sensitive to ADHD symptoms in the presence of primary hypersomnia and nightmare disorder.
According to the study, sleep problems in children with ADHD may be caused by a variety of factors, including internet addiction, hyperactivity, use of stimulants and the presence of other psychiatric disorders. Authors of the study state that the etiology of sleep problems and disorders need to be identified in children with ADHD, in order to create a modified treatment regime for sleep disorders and ADHD symptoms.
The study: "Sleep Problems and Disorders among Adolescents with Persistent and Subthreshold Attention-deficit/Hyperactivity Disorders,"
Source:
Kelly Wagner
American Academy of Sleep Medicine
Results indicate that adolescents with a childhood diagnosis of ADHD, regardless of persistent ADHD were more likely to have current sleep problems and sleep disorders such as insomnia, sleep terrors, nightmares, bruxism and snoring. Of the total sample, 17 percent of children with ADHD were currently suffering from primary insomnia, versus 7 percent of controls; lifetime primary insomnia occurred in 20 percent of children with ADHD, compared to 10 percent of controls. Nightmare disorder affected 11 percent of children with ADHD and lifetime nightmare disorder affected 23 percent, versus 5 and 16 percent of controls. The presence of at least one psychiatric comorbid condition increases the risks for insomnia and nightmares.
According to principal investigator Susan Shur-Fen Gau, MD, PhD, associate professor at the College of Medicine and Public Health, National Taiwan University, symptoms and consequences of ADHD and sleep problems in children often overlap. Some primary sleep disorders are found to be associated with inattention, hyperactivity, behavioral problems and impaired academic performance, which are often mistaken for symptoms of ADHD.
"In some patients with ADHD, symptoms are caused or exaggerated by primary sleep disorders, and therefore treatment of the sleep disorder will improve ADHD symptoms," said Gau.
Data were collected from 281 consecutive patients (86.2 percent male) between the ages of 10 to 17 years who had been diagnosed with ADHD according to DSM-IV criteria at a mean age of 6.7 years, and 185 controls who did not have ADHD as a child or teen. Diagnosis of ADHD was made based on information obtained from parent and child interviews, observation of the child's behaviors, and rating scales reported by parents and teachers.
Findings of the study indicated that the rates of nightmare and lifetime nightmare disorder were more prevalent in girls and snoring was more prevalent in boys. Snoring may be more prevalent in boys due to an increased rate of sleep-disordered breathing in boys. Mothers were found to be more aware of symptoms related to ADHD in the presence of primary insomnia, sleep terror disorder or sleepwalking disorder, whereas teachers may be more sensitive to ADHD symptoms in the presence of primary hypersomnia and nightmare disorder.
According to the study, sleep problems in children with ADHD may be caused by a variety of factors, including internet addiction, hyperactivity, use of stimulants and the presence of other psychiatric disorders. Authors of the study state that the etiology of sleep problems and disorders need to be identified in children with ADHD, in order to create a modified treatment regime for sleep disorders and ADHD symptoms.
The study: "Sleep Problems and Disorders among Adolescents with Persistent and Subthreshold Attention-deficit/Hyperactivity Disorders,"
Source:
Kelly Wagner
American Academy of Sleep Medicine
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