- Focalin XR demonstrated better symptom control versus Concerta from 30 minutes to six hours post-dose in primary and secondary endpoints - Only Focalin XR provided onset of effect as early as 30 minutes post-dose
EAST HANOVER, N.J., July 8 /PRNewswire/ -- 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.
Please see full Prescribing Information for Focalin XR including
Contraindications, Boxed Warning and Medication Guide at
http://www.FocalinXR.com or call us at 1-888-NOW-NOVA.
For further information, please visit http://www.FocalinXR.com.
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 http://www.novartis.com.
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.
The maximum approved dose is 20 mg once daily.
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SOURCE Novartis Pharmaceuticals Corporation
