Hyperkinetic disorders among children and adolescents are becoming increasingly common. In the current issue of Deutsches Arzteblatt International, Ingrid Schubert of the PMV Research Group at the University of Cologne and her colleagues address the question how this has affected the frequency of prescriptions for methylphenidate, a stimulant drug that is used to treat such disorders (Dtsch Arztebl Int 2010; 107[36]: 615?21). The authors analyzed data concerning tens of thousands of persons insured by the AOK health insurance company in the German state of Hesse over the period 2000 to 2007.
In 2007, the overall prevalence of hyperkinetic disorders among persons aged 0 to 18 years was 2.2%. This figure was nearly 50% higher than the corresponding figure for 2000. The authors found the greatest rise in prevalence in the 15- to18-year-old age group. This secular trend was particularly noteworthy for girls: among persons aged 6 to 18 years, the prevalence of hyperkinetic disorders rose by 70% among girls, as compared to 53% among boys.
In 2007, 1.1% of 6- to 18-year-olds received at least one prescription for methylphenidate. This figure corresponded to a 252% increase in daily doses prescribed in comparison to the 2000 level. The authors found that the increase was due to rises not only in the number of persons for whom me
вторник, 17 мая 2011 г.
понедельник, 16 мая 2011 г.
Study Finds Young Children Can Develop Full-blown OCD
A new study by researchers at the Bradley Hasbro Children's Research Center has found that children as young as four can develop full-blown obsessive compulsive disorder (OCD) and often exhibit many of the same OCD characteristics typically seen in older kids.
The study, published online by the Journal of Psychopathology and Behavioral Assessment, is the largest sample of young children with OCD published to date.
"There have been very few studies focusing on early childhood OCD, even though we know that OCD, if left untreated, can significantly disrupt a child's growth and development and can worsen as the child gets older," says lead author Abbe Garcia, PhD, director of the Bradley Hasbro Children's Research Center (BHCRC) Pediatric Anxiety Research Clinic. "That's why we need to understand more about OCD in very young children, since early diagnosis and intervention are critical to reducing the severity of symptoms and improving quality of life."
OCD is an anxiety disorder characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). Repetitive behaviors such as handwashing, counting, checking, or cleaning are often performed with the hope of preventing obsessive thoughts or making them go away. Performing these so-called "rituals," however, provides only temporary relief, and not performing them markedly increases anxiety. According to the American Academy of Child and Adolescent Psychiatry, as many as 1 in 200 children and adolescents struggle with OCD.
Garcia and colleagues studied 58 children with OCD between the ages of four and eight, including 23 boys and 35 girls. All children underwent a series of clinical psychological assessments. Approximately 19 percent had been previously treated with medication and 24 percent had received some form of previous psychotherapy for OCD. Twenty percent reported a first-degree family history of OCD. Nearly 22 percent of children had an additional diagnosis of attention deficit hyperactivity disorder (ADHD) and about 20 percent were also diagnosed with generalized anxiety disorder (GAD).
Common obsessions among children in the study included fear of contamination and aggressive/catastrophic fears (involving death or harm to themselves or loved ones), and three-quarters reported having multiple obsessions. Nearly all of the children suffered from multiple compulsive behaviors, with an average of four compulsions per child. Washing, checking and repeating were the most commonly reported compulsions.
A data analysis revealed a number of parallels between young children with OCD and reported samples of their older peers in terms of symptoms and severity. For example, both groups appear to have similar types of obsessions and compulsions, multiple psychiatric diagnoses, and high rates of OCD family history.
"These similarities suggest this is a study sample involving full-blown OCD, as opposed to children who are either in the beginning phases of the illness or only have a partial OCD diagnosis," says Garcia, who is also an assistant professor of psychiatry (research) at The Warren Alpert Medical School of Brown University.
However, Garcia says they also discovered some important differences between younger and older children with OCD. Although anxiety disorders seem to be a common comorbid diagnosis in both groups, younger children were less likely to have depression, compared to older children. Also, while many experts believe boys are more likely to present with juvenile OCD, the findings from the current study actually indicate a lower boy to girl ratio.
"Our findings offer the first glimpse at the features and variables that emerge during early childhood onset OCD and will hopefully lead to further studies focusing on assessment and treatment of this age group," Garcia says.
The study was supported in part by a grant from the National Institutes of Mental Health. Co-authors were Jennifer Freeman and Henrietta Leonard from the BHCRC and Alpert Medical School; Noah Berman, Alexandra Ogata and Molly Choate-Summers from the BHCRC; Michael Himle from the University of North Dakota; and Janet Ng from the University of Oregon.
Founded in 1931, Bradley Hospital, located in East Providence, RI, was the nation's first psychiatric hospital devoted exclusively for children and adolescents. Today, it remains a nationally recognized center for children's mental health care, training and research. A teaching hospital for The Warren Alpert Medical School of Brown University, Bradley Hospital offers a wide range of services for psychological, developmental and behavioral conditions, including inpatient, outpatient, residential and home-based treatment options. More than 30 postdoctoral residents and fellows in child psychiatry, psychology and pediatrics receive training in Bradley Hospital's programs every year. Its research arm, the Bradley Hasbro Children's Research Center, brings together a multidisciplinary team of investigators working to advance our knowledge of children's mental health through federally funded research projects. Bradley Hospital also operates the Bradley School, a fully certified special education school. A private, not-for-profit hospital, Bradley Hospital is a member of the Lifespan health system. For more information, please visit bradleyhospital/
Source: Jessica Collins Grimes
Lifespan
The study, published online by the Journal of Psychopathology and Behavioral Assessment, is the largest sample of young children with OCD published to date.
"There have been very few studies focusing on early childhood OCD, even though we know that OCD, if left untreated, can significantly disrupt a child's growth and development and can worsen as the child gets older," says lead author Abbe Garcia, PhD, director of the Bradley Hasbro Children's Research Center (BHCRC) Pediatric Anxiety Research Clinic. "That's why we need to understand more about OCD in very young children, since early diagnosis and intervention are critical to reducing the severity of symptoms and improving quality of life."
OCD is an anxiety disorder characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). Repetitive behaviors such as handwashing, counting, checking, or cleaning are often performed with the hope of preventing obsessive thoughts or making them go away. Performing these so-called "rituals," however, provides only temporary relief, and not performing them markedly increases anxiety. According to the American Academy of Child and Adolescent Psychiatry, as many as 1 in 200 children and adolescents struggle with OCD.
Garcia and colleagues studied 58 children with OCD between the ages of four and eight, including 23 boys and 35 girls. All children underwent a series of clinical psychological assessments. Approximately 19 percent had been previously treated with medication and 24 percent had received some form of previous psychotherapy for OCD. Twenty percent reported a first-degree family history of OCD. Nearly 22 percent of children had an additional diagnosis of attention deficit hyperactivity disorder (ADHD) and about 20 percent were also diagnosed with generalized anxiety disorder (GAD).
Common obsessions among children in the study included fear of contamination and aggressive/catastrophic fears (involving death or harm to themselves or loved ones), and three-quarters reported having multiple obsessions. Nearly all of the children suffered from multiple compulsive behaviors, with an average of four compulsions per child. Washing, checking and repeating were the most commonly reported compulsions.
A data analysis revealed a number of parallels between young children with OCD and reported samples of their older peers in terms of symptoms and severity. For example, both groups appear to have similar types of obsessions and compulsions, multiple psychiatric diagnoses, and high rates of OCD family history.
"These similarities suggest this is a study sample involving full-blown OCD, as opposed to children who are either in the beginning phases of the illness or only have a partial OCD diagnosis," says Garcia, who is also an assistant professor of psychiatry (research) at The Warren Alpert Medical School of Brown University.
However, Garcia says they also discovered some important differences between younger and older children with OCD. Although anxiety disorders seem to be a common comorbid diagnosis in both groups, younger children were less likely to have depression, compared to older children. Also, while many experts believe boys are more likely to present with juvenile OCD, the findings from the current study actually indicate a lower boy to girl ratio.
"Our findings offer the first glimpse at the features and variables that emerge during early childhood onset OCD and will hopefully lead to further studies focusing on assessment and treatment of this age group," Garcia says.
The study was supported in part by a grant from the National Institutes of Mental Health. Co-authors were Jennifer Freeman and Henrietta Leonard from the BHCRC and Alpert Medical School; Noah Berman, Alexandra Ogata and Molly Choate-Summers from the BHCRC; Michael Himle from the University of North Dakota; and Janet Ng from the University of Oregon.
Founded in 1931, Bradley Hospital, located in East Providence, RI, was the nation's first psychiatric hospital devoted exclusively for children and adolescents. Today, it remains a nationally recognized center for children's mental health care, training and research. A teaching hospital for The Warren Alpert Medical School of Brown University, Bradley Hospital offers a wide range of services for psychological, developmental and behavioral conditions, including inpatient, outpatient, residential and home-based treatment options. More than 30 postdoctoral residents and fellows in child psychiatry, psychology and pediatrics receive training in Bradley Hospital's programs every year. Its research arm, the Bradley Hasbro Children's Research Center, brings together a multidisciplinary team of investigators working to advance our knowledge of children's mental health through federally funded research projects. Bradley Hospital also operates the Bradley School, a fully certified special education school. A private, not-for-profit hospital, Bradley Hospital is a member of the Lifespan health system. For more information, please visit bradleyhospital/
Source: Jessica Collins Grimes
Lifespan
воскресенье, 15 мая 2011 г.
CME LLC Offers Education To Help Medical Professionals Better Recognize Adult ADHD
CME LLC, a leading provider of fully accredited continuing medical education programs since 1978, today announced a new interactive educational program designed to increase recognition of the complexities and complications often encountered when diagnosing and treating patients with adult ADHD.
The presentation of adult ADHD is often complicated by the presence of comorbid conditions such as depression, anxiety, bipolar disorder and substance abuse. A patient's symptoms often mask either the comorbid condition or the adult ADHD, making a diagnosis more challenging.
"Of the estimated four-to-five percent of adults with ADHD, only 20 percent are ever diagnosed, and this presents us with a tremendous opportunity to raise awareness and make a positive impact for patients and physician learners alike," said Niki Oquist, M.D., FAAP and senior vice president of medical affairs for CME LLC. "ADHD is most commonly associated with children and adolescents, and it morphs to take on a completely different form in adults. Sixty percent of children and adolescents with ADHD continue to have impairment into adulthood."
Children with ADHD have symptoms of hyperactivity and impulsiveness which progress to inattentiveness and restlessness in adults. This educational initiative is just the start of a year-long program to educate and assist physicians with diagnosing and treating patients with ADHD.
"It's easy to understand why there's so much confusion about classifying ADHD," said Oquist. "A shortage of physician training and variable symptoms may lead to the underdiagnosis of adult ADHD."
"Understanding the Complexities in the Differential Diagnosis of Adult ADHD" offers clinicians access to a Web site (adultadhd-ddx) with online anecdotal patient case studies, as well as live 4-hour meetings in Chicago; Dearborn, Mich.; Los Angeles; Washington, D.C.; and New York beginning March 1 and running through April 12. Each meeting includes two sessions: "Understanding the Challenges in the Differential Diagnosis of Adult ADHD," with Joel L. Young, M.D., medical director and founder at the Rochester Center for Behavioral Medicine and "Evaluating Treatment Strategies for Adult ADHD," with David Goodman, M.D., assistant professor for the Department of Psychiatry and Behavioral Sciences at Johns Hopkins University, the director of Suburban Psychiatric Associates, LLS and the director for the Adult Attention Deficit Disorder Center of Maryland. All course materials are peer-developed and peer-reviewed. Information and other educational opportunities will be added to the Web site throughout 2008. Meeting pre-registration is requested at adultadhd-ddx.
About CME LLC
CME LLC, a division of CMPMedica, is a leading provider of fully accredited continuing medical education programs and offers a wide range of informational and educational resources for healthcare professionals. Based in Irvine, Calif., CME produces a variety of live events and conferences, print supplements, multimedia home study products, and Web sites and is the sponsor of the U.S. Psychiatric and Mental Health Congress and Regional Extensions and the Advances series of medical education sessions, which includes Advances in Primary Care Medicine, Neurology and Pediatric Medicine.
CMELLC
The presentation of adult ADHD is often complicated by the presence of comorbid conditions such as depression, anxiety, bipolar disorder and substance abuse. A patient's symptoms often mask either the comorbid condition or the adult ADHD, making a diagnosis more challenging.
"Of the estimated four-to-five percent of adults with ADHD, only 20 percent are ever diagnosed, and this presents us with a tremendous opportunity to raise awareness and make a positive impact for patients and physician learners alike," said Niki Oquist, M.D., FAAP and senior vice president of medical affairs for CME LLC. "ADHD is most commonly associated with children and adolescents, and it morphs to take on a completely different form in adults. Sixty percent of children and adolescents with ADHD continue to have impairment into adulthood."
Children with ADHD have symptoms of hyperactivity and impulsiveness which progress to inattentiveness and restlessness in adults. This educational initiative is just the start of a year-long program to educate and assist physicians with diagnosing and treating patients with ADHD.
"It's easy to understand why there's so much confusion about classifying ADHD," said Oquist. "A shortage of physician training and variable symptoms may lead to the underdiagnosis of adult ADHD."
"Understanding the Complexities in the Differential Diagnosis of Adult ADHD" offers clinicians access to a Web site (adultadhd-ddx) with online anecdotal patient case studies, as well as live 4-hour meetings in Chicago; Dearborn, Mich.; Los Angeles; Washington, D.C.; and New York beginning March 1 and running through April 12. Each meeting includes two sessions: "Understanding the Challenges in the Differential Diagnosis of Adult ADHD," with Joel L. Young, M.D., medical director and founder at the Rochester Center for Behavioral Medicine and "Evaluating Treatment Strategies for Adult ADHD," with David Goodman, M.D., assistant professor for the Department of Psychiatry and Behavioral Sciences at Johns Hopkins University, the director of Suburban Psychiatric Associates, LLS and the director for the Adult Attention Deficit Disorder Center of Maryland. All course materials are peer-developed and peer-reviewed. Information and other educational opportunities will be added to the Web site throughout 2008. Meeting pre-registration is requested at adultadhd-ddx.
About CME LLC
CME LLC, a division of CMPMedica, is a leading provider of fully accredited continuing medical education programs and offers a wide range of informational and educational resources for healthcare professionals. Based in Irvine, Calif., CME produces a variety of live events and conferences, print supplements, multimedia home study products, and Web sites and is the sponsor of the U.S. Psychiatric and Mental Health Congress and Regional Extensions and the Advances series of medical education sessions, which includes Advances in Primary Care Medicine, Neurology and Pediatric Medicine.
CMELLC
суббота, 14 мая 2011 г.
Many Factors To Consider In Getting Treatment Right For ADHD
The quality of a child's relationships and their diet are now known to be minor risk factors implicated in attention deficit hyperactivity disorder (ADHD). Biological factors, including genetics, remain the most significant factor, however, so they must all be considered before treatment can begin.
"ADHD is rarely encountered as a pure, discrete disorder," says Professor Alasdair Vance from the Royal Children's Hospital in Melbourne. "That's why it is so important that children are properly assessed, so they can get the right support such as speech therapy, educational remediation and occupational therapy".
The first line treatment for ADHD continues to be psychosocial interventions alone, however, there is evidence that some children will do better when medicines are given in conjunction with comprehensive behavioural interventions. "Side effects also need to be well considered and understood," he says.
About Australian Prescriber
Australian Prescriber is an independent review of therapeutics. It aims to provide short direct and didactic reviews on a range of topics which will assist the readers in their professional duties.
Australian Prescriber was first published in 1975. Australian health professionals had previously been sent the British Prescribers' Journal, but this had become less relevant to Australian practice. Australian Prescriber was published by the Australian Department of Health until the National Prescribing Service assumed responsibility for the journal in 2002. Past covers of the journal make a colourful display, marking the evolution of the journal since 1975.
Australian Prescriber is distributed 6 times each year to doctors, dentists, pharmacists and students of these disciplines. The majority of readers are in Australia, but there is a growing readership in the Asia-Pacific region.
Australian Prescriber
"ADHD is rarely encountered as a pure, discrete disorder," says Professor Alasdair Vance from the Royal Children's Hospital in Melbourne. "That's why it is so important that children are properly assessed, so they can get the right support such as speech therapy, educational remediation and occupational therapy".
The first line treatment for ADHD continues to be psychosocial interventions alone, however, there is evidence that some children will do better when medicines are given in conjunction with comprehensive behavioural interventions. "Side effects also need to be well considered and understood," he says.
About Australian Prescriber
Australian Prescriber is an independent review of therapeutics. It aims to provide short direct and didactic reviews on a range of topics which will assist the readers in their professional duties.
Australian Prescriber was first published in 1975. Australian health professionals had previously been sent the British Prescribers' Journal, but this had become less relevant to Australian practice. Australian Prescriber was published by the Australian Department of Health until the National Prescribing Service assumed responsibility for the journal in 2002. Past covers of the journal make a colourful display, marking the evolution of the journal since 1975.
Australian Prescriber is distributed 6 times each year to doctors, dentists, pharmacists and students of these disciplines. The majority of readers are in Australia, but there is a growing readership in the Asia-Pacific region.
Australian Prescriber
пятница, 13 мая 2011 г.
New River Pharmaceuticals Inc. Receives Approvable Letter For NRP104
Two years after becoming a public company, New River Pharmaceuticals Inc. (Nasdaq: NRPH) has received a positive determination from the U.S. Food and Drug
Administration on its first product candidate.
The company announced that it has received an approvable letter from
the FDA for 30mg, 50mg and 70mg capsules of NRP104 (lisdexamfetamine
dimesylate), for the treatment of Attention-Deficit/Hyperactivity Disorder
(ADHD) in children aged 6 - 12. Developed by New River as a once-a-day
medication to provide efficacy throughout the day up to 6 p.m., NRP104 is a
new chemical entity in which d-amphetamine is covalently linked to
l-lysine, a naturally occurring amino acid. NRP104 remains inactive until
converted in the body and the active, d-amphetamine, is gradually released.
In January 2005, New River and Shire plc (LSE: SHP), (Nasdaq: SHPGY),
(TSX: SHQ) signed a collaboration agreement to develop and commercialize
NRP104.
According to the FDA's letter, marketing approval of NRP104 is
contingent upon final scheduling by the U.S. Drug Enforcement
Administration (DEA). No additional studies have been requested by the FDA
as a condition for approval of NRP104. New River and Shire will continue
dialog with FDA officials to agree upon a final trade name.
The Controlled Substance Staff of the FDA has initially proposed that
NRP104 be placed in Schedule II of the Controlled Substance Act. The
initial proposal will be submitted to the DEA, which is responsible for
making a final scheduling assignment. New River anticipates timely
resolution of this process.
R. J. Kirk, New River Chief Executive Officer, said, "This is a
landmark day for New River. We are pleased to have received an approvable
letter on our first drug candidate, and we view this as a significant step
toward bringing NRP104 to market. Pending final labeling discussions and a
scheduling assignment from the DEA, we are preparing for a product launch
in the second quarter of 2007."
"This approvable letter for NRP104 is positive news for Shire and its
partner New River," said Shire Chief Executive Officer Matthew Emmens. "We
look forward to working with New River to bring NRP104 to market. We
believe NRP104 will offer patients, their families, and healthcare
providers the next generation of ADHD treatment."
Kirk also noted, "As we work toward final approval of NRP104, we
continue progress on the development of our other pipeline drug candidates,
including NRP290 to treat acute pain, and NRP409, which, if approved,
should mark the first significant improvement in thyroid hormone
replacement therapy in half a century."
The Collaboration Agreement
Under the terms of the agreement, the parties will collaborate on
NRP104 development, manufacturing, marketing and sales in the U.S. Shire
will book the product sales and New River may supply up to 25 percent of
the sales effort under a co-promotion right. New River will be financially
and operationally responsible for clinical and manufacturing development.
New River plans to file a Current Report on Form 8-K with the U.S.
Securities and Exchange Commission providing additional details on the
company's U.S. collaboration agreement with Shire.
Upon receiving marketing approval in the U.S., the agreement requires
Shire to launch and commercialize NRP104 carrying out its obligations and
tasks consistent with the reasonable best practices of the pharmaceutical
industry for the development or commercialization of a pharmaceutical
product having similar market potential, profit potential or strategic
value, based on conditions then prevailing. The agreement also obligates
Shire to give NRP104 marketing and promotional priority over its other oral
ADHD stimulants should NRP104's label contain a claim relating to a
decreased potential for abuse or overdose protection.
Under the agreement, in the event that NRP104 is approved with a
Schedule III, IV or V classification or be unscheduled ("favorable
scheduling"), the parties will divide operating profit as follows: New
River will receive 25 percent of profits for the first two years following
launch, and the parties will share the profits equally thereafter. However,
in the event that NRP104 receives a final Schedule II classification, the
collaboration agreement allows for an alternative profit-sharing scheme.
Under this scenario, New River's share of U.S. product profits for the
first two years will be at least 25%, though it may increase to a value
determined by a preset formula. After the first two years, it will be at
least 50%, though it may increase to a value determined by a preset
formula. These formulas, which include yearly threshold sales, will be
included in the Current Report on Form 8-K New River intends to file.
Shire paid an initial sum of $50 million on signing the collaboration
agreement and $50 million upon acceptance of the filing of the New Drug
Application by the FDA. Should NRP104 receive favorable scheduling by its
first commercial sale, the agreement entitles New River to a $300 million
milestone payment. Should NRP104 launch under a Schedule II classification
but receive favorable scheduling within 3 years of the first commercial
sale, the agreement provides for an alternative milestone payment on a
sliding scale as follows: if the favorable scheduling occurs within one
year of the first commercial sale, the milestone payment will be $200
million; if it occurs by the third anniversary, the milestone payment will
be $100 million.
In addition, New River will be entitled to a $100 million milestone
payment at the end of the first calendar year in which cumulative worldwide
net sales of all collaboration products during that calendar year exceed $1
billion.
Shire is entitled to terminate the agreement until 30 days following
approval of NRP104. If Shire terminates before regulatory approval, no
payment would be due Shire. If Shire terminates after approval and NRP104
has received a favorable scheduling assignment, no payment would be due
Shire. If the approved NRP104 has received a Schedule II classification,
Shire would be entitled to a $50 million termination payment, payable in
cash, New River common stock, or an unsecured, 5-year promissory note, as
will be agreed upon by Shire and New River.
About ADHD
ADHD affects approximately 7.8 percent of all school-age children, or
about 4.4 million children in the U.S.(i) ADHD is considered the most
commonly diagnosed psychiatric disorder in children and adolescents.(ii)
ADHD is a neurobiological disorder that manifests as a persistent pattern
of inattention and/or hyperactivity-impulsivity more frequent and severe
than typically observed in individuals at a comparable level of
development.(iii) To be properly diagnosed with ADHD, a child needs to
demonstrate at least six of nine symptoms of inattention; at least six of
nine symptoms of hyperactivity/impulsivity; the onset of such symptoms
before age 7 years; that some impairment from the symptoms is present in
two or more settings (e.g., at school and home); and that the symptoms
continue for at least six months.(iv) If untreated, ADHD can acutely affect
a child's life, leading to problems with family members, friends, sports,
after-school activities and academics.(v)
Although there is no "cure" for ADHD, there are accepted treatments
that specifically target its symptoms. The most common standard treatments
include educational approaches, psychological or behavioral modification,
and medication.(vi)
About New River
New River Pharmaceuticals Inc. is a specialty pharmaceutical company
developing novel pharmaceuticals that are generational improvements of
widely prescribed drugs in large and growing markets.
For further information on New River, please visit the company's
website at nrpharma.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
This press release contains certain forward-looking information that is
intended to be covered by the safe harbor for "forward-looking statements"
provided by the Private Securities Litigation Reform Act of 1995. Forward-
looking statements are statements that are not historical facts. Words such
as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and
similar expressions are intended to identify forward-looking statements.
These statements include, but are not limited to, financial projections and
estimates and their underlying assumptions; statements regarding plans,
objectives and expectations with respect to future operations, products and
services; and statements regarding future performance. Such statements are
subject to certain risks and uncertainties, many of which are difficult to
predict and generally beyond the control of New River Pharmaceuticals, that
could cause actual results to differ materially from those expressed in, or
implied or projected by, the forward-looking information and statements.
These risks and uncertainties include: those discussed and identified in
the New River Pharmaceuticals Inc. annual report on Form 10-K, filed with
the SEC on March 15, 2006; the timing, progress and likelihood of success
of our product research and development programs; the timing and status of
our preclinical and clinical development of potential drugs; the likelihood
of success of our drug products in clinical trials and the regulatory
approval process; our drug products' efficacy, abuse and tamper resistance,
resistance to intravenous abuse, onset and duration of drug action, ability
to provide protection from overdose, ability to improve patients' symptoms,
incidence of adverse events, ability to reduce opioid tolerance, ability to
reduce therapeutic variability, and ability to reduce the risks associated
with certain therapies; the ability to develop, manufacture, launch and
market our drug products; our projections for future revenues,
profitability and ability to achieve certain threshold sales targets; our
estimates regarding our capital requirements and our needs for additional
financing; the likelihood of obtaining favorable scheduling and labeling of
our drug products; the likelihood of regulatory approval under the Federal
Food, Drug, and Cosmetic Act without having to conduct long and costly
trials to generate all of the data which are often required in connection
with a traditional new chemical entity; our ability to develop safer and
improved versions of widely prescribed drugs using our Carrierwave (TM)
technology; our success in developing our own sales and marketing
capabilities for our lead product candidate, NRP104; and our ability to
obtain favorable patent claims. Readers are cautioned not to place undue
reliance on these forward-looking statements that speak only as of the date
hereof. New River Pharmaceuticals does not undertake any obligation to
republish revised forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events. Readers are also urged to carefully review and
consider the various disclosures in New River Pharmaceuticals' annual
report on Form 10-K, filed with the SEC on March 15, 2006, as well as other
public filings with the SEC.
(i) Mental health in the United States: prevalence of diagnosis and
medication treatment for attention-deficit/hyperactivity disorder, United
States, 2003," CDC MMWR, September 2, 2005; 54(34); 842-847. Available at:
cdc.gov/mmwr/preview/mmwrhtml/mm5434a2.htm. Accessed on
September 8, 2005.
(ii) American Academy of Child and Adolescent Psychiatry. Practice
parameters for the assessment and treatment of children, adolescents, and
adults with attention-deficit/hyperactivity disorder. J Am Acad Child
Adolesc Psychiatry. 1997; 36(10 Suppl):855-1215. Introduction. Available at
aacap/clinical/Adhdsum.htm. Accessed on September 16, 2005.
(iii) WebMD Health. The Facts About Adult ADHD page. Available at:
http://my.webmd/content/article/66/79706.htm?lastselectedguid={5FE84E90 . Accessed on March 8, 2004.
(iv) Diagnostic and Statistical Manual of Mental Disorders: Fourth
Edition, Text Revision. DSM-TR-IV(R). Washington, DC: American Psychiatric
Association; 2000: 85.
(v) "Introduction," Diagnosis and Treatment of Attention Deficit
Hyperactivity Disorder. NIH Consensus Statement 1998 Nov 16-18; 16(2):
1-37. Available at:
http://consensus.nih.gov/cons/110/110_statement.htm#0_Abstract. Accessed on
June 8, 2005.
(vi) Baumgartel A, et al. Practice guideline for the diagnosis and
management of attention deficit hyperactivity disorder. Ambulatory Child
Health. 1998;4:51.
New River Pharmaceuticals Inc
nrpharma
Administration on its first product candidate.
The company announced that it has received an approvable letter from
the FDA for 30mg, 50mg and 70mg capsules of NRP104 (lisdexamfetamine
dimesylate), for the treatment of Attention-Deficit/Hyperactivity Disorder
(ADHD) in children aged 6 - 12. Developed by New River as a once-a-day
medication to provide efficacy throughout the day up to 6 p.m., NRP104 is a
new chemical entity in which d-amphetamine is covalently linked to
l-lysine, a naturally occurring amino acid. NRP104 remains inactive until
converted in the body and the active, d-amphetamine, is gradually released.
In January 2005, New River and Shire plc (LSE: SHP), (Nasdaq: SHPGY),
(TSX: SHQ) signed a collaboration agreement to develop and commercialize
NRP104.
According to the FDA's letter, marketing approval of NRP104 is
contingent upon final scheduling by the U.S. Drug Enforcement
Administration (DEA). No additional studies have been requested by the FDA
as a condition for approval of NRP104. New River and Shire will continue
dialog with FDA officials to agree upon a final trade name.
The Controlled Substance Staff of the FDA has initially proposed that
NRP104 be placed in Schedule II of the Controlled Substance Act. The
initial proposal will be submitted to the DEA, which is responsible for
making a final scheduling assignment. New River anticipates timely
resolution of this process.
R. J. Kirk, New River Chief Executive Officer, said, "This is a
landmark day for New River. We are pleased to have received an approvable
letter on our first drug candidate, and we view this as a significant step
toward bringing NRP104 to market. Pending final labeling discussions and a
scheduling assignment from the DEA, we are preparing for a product launch
in the second quarter of 2007."
"This approvable letter for NRP104 is positive news for Shire and its
partner New River," said Shire Chief Executive Officer Matthew Emmens. "We
look forward to working with New River to bring NRP104 to market. We
believe NRP104 will offer patients, their families, and healthcare
providers the next generation of ADHD treatment."
Kirk also noted, "As we work toward final approval of NRP104, we
continue progress on the development of our other pipeline drug candidates,
including NRP290 to treat acute pain, and NRP409, which, if approved,
should mark the first significant improvement in thyroid hormone
replacement therapy in half a century."
The Collaboration Agreement
Under the terms of the agreement, the parties will collaborate on
NRP104 development, manufacturing, marketing and sales in the U.S. Shire
will book the product sales and New River may supply up to 25 percent of
the sales effort under a co-promotion right. New River will be financially
and operationally responsible for clinical and manufacturing development.
New River plans to file a Current Report on Form 8-K with the U.S.
Securities and Exchange Commission providing additional details on the
company's U.S. collaboration agreement with Shire.
Upon receiving marketing approval in the U.S., the agreement requires
Shire to launch and commercialize NRP104 carrying out its obligations and
tasks consistent with the reasonable best practices of the pharmaceutical
industry for the development or commercialization of a pharmaceutical
product having similar market potential, profit potential or strategic
value, based on conditions then prevailing. The agreement also obligates
Shire to give NRP104 marketing and promotional priority over its other oral
ADHD stimulants should NRP104's label contain a claim relating to a
decreased potential for abuse or overdose protection.
Under the agreement, in the event that NRP104 is approved with a
Schedule III, IV or V classification or be unscheduled ("favorable
scheduling"), the parties will divide operating profit as follows: New
River will receive 25 percent of profits for the first two years following
launch, and the parties will share the profits equally thereafter. However,
in the event that NRP104 receives a final Schedule II classification, the
collaboration agreement allows for an alternative profit-sharing scheme.
Under this scenario, New River's share of U.S. product profits for the
first two years will be at least 25%, though it may increase to a value
determined by a preset formula. After the first two years, it will be at
least 50%, though it may increase to a value determined by a preset
formula. These formulas, which include yearly threshold sales, will be
included in the Current Report on Form 8-K New River intends to file.
Shire paid an initial sum of $50 million on signing the collaboration
agreement and $50 million upon acceptance of the filing of the New Drug
Application by the FDA. Should NRP104 receive favorable scheduling by its
first commercial sale, the agreement entitles New River to a $300 million
milestone payment. Should NRP104 launch under a Schedule II classification
but receive favorable scheduling within 3 years of the first commercial
sale, the agreement provides for an alternative milestone payment on a
sliding scale as follows: if the favorable scheduling occurs within one
year of the first commercial sale, the milestone payment will be $200
million; if it occurs by the third anniversary, the milestone payment will
be $100 million.
In addition, New River will be entitled to a $100 million milestone
payment at the end of the first calendar year in which cumulative worldwide
net sales of all collaboration products during that calendar year exceed $1
billion.
Shire is entitled to terminate the agreement until 30 days following
approval of NRP104. If Shire terminates before regulatory approval, no
payment would be due Shire. If Shire terminates after approval and NRP104
has received a favorable scheduling assignment, no payment would be due
Shire. If the approved NRP104 has received a Schedule II classification,
Shire would be entitled to a $50 million termination payment, payable in
cash, New River common stock, or an unsecured, 5-year promissory note, as
will be agreed upon by Shire and New River.
About ADHD
ADHD affects approximately 7.8 percent of all school-age children, or
about 4.4 million children in the U.S.(i) ADHD is considered the most
commonly diagnosed psychiatric disorder in children and adolescents.(ii)
ADHD is a neurobiological disorder that manifests as a persistent pattern
of inattention and/or hyperactivity-impulsivity more frequent and severe
than typically observed in individuals at a comparable level of
development.(iii) To be properly diagnosed with ADHD, a child needs to
demonstrate at least six of nine symptoms of inattention; at least six of
nine symptoms of hyperactivity/impulsivity; the onset of such symptoms
before age 7 years; that some impairment from the symptoms is present in
two or more settings (e.g., at school and home); and that the symptoms
continue for at least six months.(iv) If untreated, ADHD can acutely affect
a child's life, leading to problems with family members, friends, sports,
after-school activities and academics.(v)
Although there is no "cure" for ADHD, there are accepted treatments
that specifically target its symptoms. The most common standard treatments
include educational approaches, psychological or behavioral modification,
and medication.(vi)
About New River
New River Pharmaceuticals Inc. is a specialty pharmaceutical company
developing novel pharmaceuticals that are generational improvements of
widely prescribed drugs in large and growing markets.
For further information on New River, please visit the company's
website at nrpharma.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
This press release contains certain forward-looking information that is
intended to be covered by the safe harbor for "forward-looking statements"
provided by the Private Securities Litigation Reform Act of 1995. Forward-
looking statements are statements that are not historical facts. Words such
as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and
similar expressions are intended to identify forward-looking statements.
These statements include, but are not limited to, financial projections and
estimates and their underlying assumptions; statements regarding plans,
objectives and expectations with respect to future operations, products and
services; and statements regarding future performance. Such statements are
subject to certain risks and uncertainties, many of which are difficult to
predict and generally beyond the control of New River Pharmaceuticals, that
could cause actual results to differ materially from those expressed in, or
implied or projected by, the forward-looking information and statements.
These risks and uncertainties include: those discussed and identified in
the New River Pharmaceuticals Inc. annual report on Form 10-K, filed with
the SEC on March 15, 2006; the timing, progress and likelihood of success
of our product research and development programs; the timing and status of
our preclinical and clinical development of potential drugs; the likelihood
of success of our drug products in clinical trials and the regulatory
approval process; our drug products' efficacy, abuse and tamper resistance,
resistance to intravenous abuse, onset and duration of drug action, ability
to provide protection from overdose, ability to improve patients' symptoms,
incidence of adverse events, ability to reduce opioid tolerance, ability to
reduce therapeutic variability, and ability to reduce the risks associated
with certain therapies; the ability to develop, manufacture, launch and
market our drug products; our projections for future revenues,
profitability and ability to achieve certain threshold sales targets; our
estimates regarding our capital requirements and our needs for additional
financing; the likelihood of obtaining favorable scheduling and labeling of
our drug products; the likelihood of regulatory approval under the Federal
Food, Drug, and Cosmetic Act without having to conduct long and costly
trials to generate all of the data which are often required in connection
with a traditional new chemical entity; our ability to develop safer and
improved versions of widely prescribed drugs using our Carrierwave (TM)
technology; our success in developing our own sales and marketing
capabilities for our lead product candidate, NRP104; and our ability to
obtain favorable patent claims. Readers are cautioned not to place undue
reliance on these forward-looking statements that speak only as of the date
hereof. New River Pharmaceuticals does not undertake any obligation to
republish revised forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events. Readers are also urged to carefully review and
consider the various disclosures in New River Pharmaceuticals' annual
report on Form 10-K, filed with the SEC on March 15, 2006, as well as other
public filings with the SEC.
(i) Mental health in the United States: prevalence of diagnosis and
medication treatment for attention-deficit/hyperactivity disorder, United
States, 2003," CDC MMWR, September 2, 2005; 54(34); 842-847. Available at:
cdc.gov/mmwr/preview/mmwrhtml/mm5434a2.htm. Accessed on
September 8, 2005.
(ii) American Academy of Child and Adolescent Psychiatry. Practice
parameters for the assessment and treatment of children, adolescents, and
adults with attention-deficit/hyperactivity disorder. J Am Acad Child
Adolesc Psychiatry. 1997; 36(10 Suppl):855-1215. Introduction. Available at
aacap/clinical/Adhdsum.htm. Accessed on September 16, 2005.
(iii) WebMD Health. The Facts About Adult ADHD page. Available at:
http://my.webmd/content/article/66/79706.htm?lastselectedguid={5FE84E90 . Accessed on March 8, 2004.
(iv) Diagnostic and Statistical Manual of Mental Disorders: Fourth
Edition, Text Revision. DSM-TR-IV(R). Washington, DC: American Psychiatric
Association; 2000: 85.
(v) "Introduction," Diagnosis and Treatment of Attention Deficit
Hyperactivity Disorder. NIH Consensus Statement 1998 Nov 16-18; 16(2):
1-37. Available at:
http://consensus.nih.gov/cons/110/110_statement.htm#0_Abstract. Accessed on
June 8, 2005.
(vi) Baumgartel A, et al. Practice guideline for the diagnosis and
management of attention deficit hyperactivity disorder. Ambulatory Child
Health. 1998;4:51.
New River Pharmaceuticals Inc
nrpharma
вторник, 10 мая 2011 г.
Children With ADHD At Increased Risk For Depression And Suicidal Thoughts As Adolescents
Children diagnosed with attention deficit/hyperactivity disorder (ADHD) at ages 4 to 6 are more likely to suffer from depression as adolescents than those who did not have ADHD at that age, according to a long-term study published in the October issue of the Archives of General Psychiatry. Although it was an uncommon occurrence, the children with ADHD also were somewhat more likely to think about or attempt suicide as adolescents.
"This study is important in demonstrating that, even during early childhood, ADHD in is seldom transient or unimportant" said study director Benjamin Lahey, Ph.D., a professor of health studies and psychiatry at the University of Chicago. "It reinforces our belief that parents of young children with ADHD should pay close attention to their child's behavior and its consequences and seek treatment to prevent possible long-term problems."
Children with ADHD have trouble paying attention and controlling impulsive behaviors and are often overly active. This can cause poor performance in school, difficulties in social situations, and a loss of confidence and self esteem. The Centers for Disease Control and Prevention estimate that about 4.4 million children, including about four percent of those aged 4 to 6, have ADHD.
Earlier studies of the long-term connections between ADHD, depression and suicidal thoughts produced mixed results. This study benefited from a more comprehensive assessment of depression over a decade, a focus on specific child and family factors that predict which children are most at risk, and consideration of other factors associated with suicidal ideas.
The study, performed by researchers at the University of Chicago and the University of Pittsburgh, followed 123 children diagnosed with ADHD at age 4 to 6 for up to 14 years, until they reached ages 18 to 20. It compared them with 119 children from similar neighborhoods and schools, matched for age, sex, and ethnicity. The children were assessed annually in study years 1 through 4, 6 through 9, and 12 through 14.
The researchers found that 18 percent of children diagnosed early with ADHD suffered from depression as adolescents, about 10 times the rate among those without ADHD. Children with early ADHD were five times as likely to have considered suicide at least once, and twice as likely to have made an attempt.
"Suicide attempts were relatively rare, even in the study group," cautioned Lahey. "Parents should keep in mind that more than 80 percent of the children with ADHD did not attempt suicide and no one in this study committed suicide."
Although the subtypes of ADHD--based on whether they had attention deficit or hyperactivity or both--predict subsequent depression and suicidal thoughts, distinct forms of the disease at age 4 to 6 were moderately predictive for specific problems later on. Children with inattention or combined subtype were at greater risk for depression. Those with combined type or hyperactivity were at greater risk for suicidal thoughts.
Far more boys that girls suffer from ADHD, but being female increased the risk of depression. Children whose mothers suffered from depression were also at increased risk.
Children with more complicated ADHD were most at risk, the authors conclude. "Greater numbers of depression, anxiety, oppositional defiant disorder, and conduct disorder symptoms at ages 4 to 6 among children with ADHD robustly predicted risk for depression during adolescence. Children with uncomplicated ADHD with few concurrent symptoms of other disorders were at low risk for depression, but children with many concurrent symptoms were at very high risk."
The National Institutes of Health funded this study Additional authors include Andrea Chronis-Tuscano, PhD, of the University of Maryland; Brooke Molina, PhD, of the University of Pittsburgh; William Pelham, PhD, of Florida International University; Brooks Applegate, PhD, of Western Michigan University; and Allison Dahlke and Meghan Overmyer of the University of Chicago.
Source: University of Chicago Medical Center
"This study is important in demonstrating that, even during early childhood, ADHD in is seldom transient or unimportant" said study director Benjamin Lahey, Ph.D., a professor of health studies and psychiatry at the University of Chicago. "It reinforces our belief that parents of young children with ADHD should pay close attention to their child's behavior and its consequences and seek treatment to prevent possible long-term problems."
Children with ADHD have trouble paying attention and controlling impulsive behaviors and are often overly active. This can cause poor performance in school, difficulties in social situations, and a loss of confidence and self esteem. The Centers for Disease Control and Prevention estimate that about 4.4 million children, including about four percent of those aged 4 to 6, have ADHD.
Earlier studies of the long-term connections between ADHD, depression and suicidal thoughts produced mixed results. This study benefited from a more comprehensive assessment of depression over a decade, a focus on specific child and family factors that predict which children are most at risk, and consideration of other factors associated with suicidal ideas.
The study, performed by researchers at the University of Chicago and the University of Pittsburgh, followed 123 children diagnosed with ADHD at age 4 to 6 for up to 14 years, until they reached ages 18 to 20. It compared them with 119 children from similar neighborhoods and schools, matched for age, sex, and ethnicity. The children were assessed annually in study years 1 through 4, 6 through 9, and 12 through 14.
The researchers found that 18 percent of children diagnosed early with ADHD suffered from depression as adolescents, about 10 times the rate among those without ADHD. Children with early ADHD were five times as likely to have considered suicide at least once, and twice as likely to have made an attempt.
"Suicide attempts were relatively rare, even in the study group," cautioned Lahey. "Parents should keep in mind that more than 80 percent of the children with ADHD did not attempt suicide and no one in this study committed suicide."
Although the subtypes of ADHD--based on whether they had attention deficit or hyperactivity or both--predict subsequent depression and suicidal thoughts, distinct forms of the disease at age 4 to 6 were moderately predictive for specific problems later on. Children with inattention or combined subtype were at greater risk for depression. Those with combined type or hyperactivity were at greater risk for suicidal thoughts.
Far more boys that girls suffer from ADHD, but being female increased the risk of depression. Children whose mothers suffered from depression were also at increased risk.
Children with more complicated ADHD were most at risk, the authors conclude. "Greater numbers of depression, anxiety, oppositional defiant disorder, and conduct disorder symptoms at ages 4 to 6 among children with ADHD robustly predicted risk for depression during adolescence. Children with uncomplicated ADHD with few concurrent symptoms of other disorders were at low risk for depression, but children with many concurrent symptoms were at very high risk."
The National Institutes of Health funded this study Additional authors include Andrea Chronis-Tuscano, PhD, of the University of Maryland; Brooke Molina, PhD, of the University of Pittsburgh; William Pelham, PhD, of Florida International University; Brooks Applegate, PhD, of Western Michigan University; and Allison Dahlke and Meghan Overmyer of the University of Chicago.
Source: University of Chicago Medical Center
понедельник, 9 мая 2011 г.
Mixed Amphetamine Salts Extended Release Improves Information Processing In Adults With ADHD
Toronto, Canada - Mixed amphetamine salts extended release (MAS XR) substantially improved the speed and accuracy in information processing of adults with attention-deficit/hyperactivity disorder (ADHD), according to a study presented today at the annual American Psychiatric Association Meeting in Toronto, Canada.
"ADHD affects cognitive functioning - how people process information - and can interfere with the efficiency of completing tasks primarily due to the deficits in attention and executive functions," said investigator Gary Kay, Ph.D., president of the Washington Neuropsychological Institute. "Our analyses demonstrate that mixed amphetamine salts help people with ADHD to respond to a number of demanding cognitive tasks with more speed and accuracy."
In this study, participants started taking mixed amphetamine salts extended release or placebo for three weeks and were then switched to the other treatment while being evaluated by the same battery of tests. In a study of 14, participants who took MAS XR performed significantly better than those taking placebo on four variables, demonstrating improvements in divided attention, visuospatial working memory, visual scanning and tracking, and mental flexibility.
Assessment of cognitive functioning was conducted with the computer-administered CogScreen - Aeromedical Edition test, a test battery originally developed under contract to the Federal Aviation Administration for evaluating pilots. This validated test battery assesses visual and auditory attention and includes measures of working memory, information processing speed, mental flexibility, and divided attention. CogScreen is used by airlines as a predictor of flight performance and by biomedical researchers investigating the beneficial or adverse effects of medications on neurocognitive functioning.
"One unexpected finding was that patients who received mixed amphetamine salts extended release in the first treatment period and who were then switched to placebo for the second treatment period either maintained or improved their accuracy and response speed despite no longer receiving the medication," said Dr. Kay. "This finding suggests some lasting effects of psychostimulant treatment on certain aspects of neurocognitive processing in young adults with ADHD, underscoring the importance of treating ADHD early and appropriately," continued Kay.
Example: CogScreen Matching to Sample Test
Participants given a placebo before switching to mixed amphetamine salts extended release improved the accuracy of their responses (mean scores improved from 92.64 percent correct to 97.16 percent correct) on the Matching to Sample Test. This is a visual-spatial working memory test that requires participants to remember a checkerboard pattern and then identify that pattern after a brief delay. Patients given MAS XR in the first treatment period performed better than those receiving placebo (95.16 percent correct) and appeared to largely maintain this accuracy when taking placebo (94.32 percent correct).
This improvement in accuracy with MAS XR was paralleled by improvements in response speed. Patients receiving placebo in the first treatment phase had a mean response speed of 1.17 seconds. Their response speed improved to 1.04 seconds when taking MAS XR. Patients who received MAS XR in the first treatment phase demonstrated good response speed (1.07 seconds) and maintained their rapid response times when switched to placebo (1.06 seconds).
Additional Study Information
Investigators evaluated 17 adult participants, aged 19 to 25, in this six-week, double-blind, placebo-controlled, randomized two-way cross-over study. Neurocognitive results are based on 14 completers. Subjects were administered the CogScreen test battery twice during screening to become familiar with the cognitive tasks. At the completion of each 3-week treatment phase they were administered the CogScreen test battery four times; at 0 hours, 2 hours, 7 hours and 12 hours post-dose. When treated with MAS XR, participants received 20 milligrams (mg) daily during week one, followed by 40 mg/day during week two and 50 mg/day during week three.
MAS XR was well tolerated in the study. Thirty days after the final dose of MAS XR, participants received a follow-up phone call inquiring about any new-onset and serious adverse events.
About Washington Neuropsychological Institute
The Washington Neuropsychological Institute is a private, independent research organization that conducts clinical research trials and provides consulting services to government agencies and to the pharmaceutical industry. At their Northwest Washington, DC facility WNI has conducted studies on antihistamines, anticholinergics, memory enhancement drugs, jet lag remedies, head trauma, epilepsy, diabetes, Parkinson's Disease, Alzheimer's Disease, and ADHD. WNI is fully equipped to support Phase III and Phase IV clinical trials. The institute specializes in computer-based neurocognitive testing and driving simulation. In addition, professional staff members are frequent lecturers at national and international medical and scientific meetings.
About ADHD
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 typically observed in individuals at a comparable age and maturity level. Because everyone shows signs of these behaviors at times, the behaviors must appear early in life (before age 7 years) and continue for at least six months, according to the ADHD diagnosis criteria as defined in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR?). Up to 65 percent of children with ADHD may still exhibit symptoms into adulthood. In fact, approximately eight million American adults currently struggle with the inattention, impulsivity and hyperactivity symptoms of ADHD.
Without an effective treatment program, the symptoms of ADHD may lead to potentially serious consequences. A survey has shown that when compared to adults without ADHD symptoms, adults with untreated ADHD were more than twice as likely to have been arrested, 47 percent more likely to have received more than one speeding ticket in the last year, twice as likely to have been divorced and twice as likely to have held six or more jobs in the past decade. Further, evidence suggests that many adults with untreated ADHD may be at risk for other problems, including poor performance in the workplace and poor self-image.
Although there is no cure for ADHD, physicians and advocates are finding ways to help people with the condition learn to adapt to their school, home, social and work settings. ADHD usually can be successfully managed with behavioral therapy, structured coping techniques and medication. Psychostimulant medications are thought to stimulate areas of the brain that control attention, impulses, and self-regulation of behavior, remain among the most successful treatments for people with ADHD. Up to 70 percent of children with ADHD respond positively to psychostimulants. Medication should be considered part of an overall multi-modal treatment plan for ADHD.
Priya Namjoshi
Porter Novelli
porternovelli/
"ADHD affects cognitive functioning - how people process information - and can interfere with the efficiency of completing tasks primarily due to the deficits in attention and executive functions," said investigator Gary Kay, Ph.D., president of the Washington Neuropsychological Institute. "Our analyses demonstrate that mixed amphetamine salts help people with ADHD to respond to a number of demanding cognitive tasks with more speed and accuracy."
In this study, participants started taking mixed amphetamine salts extended release or placebo for three weeks and were then switched to the other treatment while being evaluated by the same battery of tests. In a study of 14, participants who took MAS XR performed significantly better than those taking placebo on four variables, demonstrating improvements in divided attention, visuospatial working memory, visual scanning and tracking, and mental flexibility.
Assessment of cognitive functioning was conducted with the computer-administered CogScreen - Aeromedical Edition test, a test battery originally developed under contract to the Federal Aviation Administration for evaluating pilots. This validated test battery assesses visual and auditory attention and includes measures of working memory, information processing speed, mental flexibility, and divided attention. CogScreen is used by airlines as a predictor of flight performance and by biomedical researchers investigating the beneficial or adverse effects of medications on neurocognitive functioning.
"One unexpected finding was that patients who received mixed amphetamine salts extended release in the first treatment period and who were then switched to placebo for the second treatment period either maintained or improved their accuracy and response speed despite no longer receiving the medication," said Dr. Kay. "This finding suggests some lasting effects of psychostimulant treatment on certain aspects of neurocognitive processing in young adults with ADHD, underscoring the importance of treating ADHD early and appropriately," continued Kay.
Example: CogScreen Matching to Sample Test
Participants given a placebo before switching to mixed amphetamine salts extended release improved the accuracy of their responses (mean scores improved from 92.64 percent correct to 97.16 percent correct) on the Matching to Sample Test. This is a visual-spatial working memory test that requires participants to remember a checkerboard pattern and then identify that pattern after a brief delay. Patients given MAS XR in the first treatment period performed better than those receiving placebo (95.16 percent correct) and appeared to largely maintain this accuracy when taking placebo (94.32 percent correct).
This improvement in accuracy with MAS XR was paralleled by improvements in response speed. Patients receiving placebo in the first treatment phase had a mean response speed of 1.17 seconds. Their response speed improved to 1.04 seconds when taking MAS XR. Patients who received MAS XR in the first treatment phase demonstrated good response speed (1.07 seconds) and maintained their rapid response times when switched to placebo (1.06 seconds).
Additional Study Information
Investigators evaluated 17 adult participants, aged 19 to 25, in this six-week, double-blind, placebo-controlled, randomized two-way cross-over study. Neurocognitive results are based on 14 completers. Subjects were administered the CogScreen test battery twice during screening to become familiar with the cognitive tasks. At the completion of each 3-week treatment phase they were administered the CogScreen test battery four times; at 0 hours, 2 hours, 7 hours and 12 hours post-dose. When treated with MAS XR, participants received 20 milligrams (mg) daily during week one, followed by 40 mg/day during week two and 50 mg/day during week three.
MAS XR was well tolerated in the study. Thirty days after the final dose of MAS XR, participants received a follow-up phone call inquiring about any new-onset and serious adverse events.
About Washington Neuropsychological Institute
The Washington Neuropsychological Institute is a private, independent research organization that conducts clinical research trials and provides consulting services to government agencies and to the pharmaceutical industry. At their Northwest Washington, DC facility WNI has conducted studies on antihistamines, anticholinergics, memory enhancement drugs, jet lag remedies, head trauma, epilepsy, diabetes, Parkinson's Disease, Alzheimer's Disease, and ADHD. WNI is fully equipped to support Phase III and Phase IV clinical trials. The institute specializes in computer-based neurocognitive testing and driving simulation. In addition, professional staff members are frequent lecturers at national and international medical and scientific meetings.
About ADHD
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 typically observed in individuals at a comparable age and maturity level. Because everyone shows signs of these behaviors at times, the behaviors must appear early in life (before age 7 years) and continue for at least six months, according to the ADHD diagnosis criteria as defined in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR?). Up to 65 percent of children with ADHD may still exhibit symptoms into adulthood. In fact, approximately eight million American adults currently struggle with the inattention, impulsivity and hyperactivity symptoms of ADHD.
Without an effective treatment program, the symptoms of ADHD may lead to potentially serious consequences. A survey has shown that when compared to adults without ADHD symptoms, adults with untreated ADHD were more than twice as likely to have been arrested, 47 percent more likely to have received more than one speeding ticket in the last year, twice as likely to have been divorced and twice as likely to have held six or more jobs in the past decade. Further, evidence suggests that many adults with untreated ADHD may be at risk for other problems, including poor performance in the workplace and poor self-image.
Although there is no cure for ADHD, physicians and advocates are finding ways to help people with the condition learn to adapt to their school, home, social and work settings. ADHD usually can be successfully managed with behavioral therapy, structured coping techniques and medication. Psychostimulant medications are thought to stimulate areas of the brain that control attention, impulses, and self-regulation of behavior, remain among the most successful treatments for people with ADHD. Up to 70 percent of children with ADHD respond positively to psychostimulants. Medication should be considered part of an overall multi-modal treatment plan for ADHD.
Priya Namjoshi
Porter Novelli
porternovelli/
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