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.
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