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Old 10-27-04, 11:50 AM
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Focalin XR Results

Focalin(TM) XR Helps Manage ADHD Symptoms for 12 Hours

WASHINGTON, Oct. 25 /PRNewswire-FirstCall/ -- An investigational
medication may help adults and children manage Attention-Deficit/Hyperactivity
Disorder (ADHD) symptoms, according to three separate studies presented at the
51st Annual Meeting of the American Academy of Child and Adolescent Psychiatry
(AACAP). Results from one of the pediatric studies show that Focalin(TM) XR
(dexmethylphenidate HCl) extended release capsules may help treat ADHD
symptoms for 12 hours.
In children and adults, the core symptoms of ADHD are inattention,
impulsivity and hyperactivity; however, in adults symptoms of hyperactivity
often subside with maturity or may manifest differently. ADHD is one of the
most common psychiatric disorders of childhood and is estimated to affect five
to seven percent of children. Many children with ADHD will continue to
experience symptoms into adulthood. ADHD is estimated to affect approximately
four percent of the adult population.
"Untreated, ADHD can have serious consequences for both children and adult
patients. These include impaired performance at work and school, and poor
relationships with peers and family members. Identification and treatment of
the disorder at any age can help improve these situations," said Lenard Adler,
M.D. Associate Professor of Clinical Psychiatry and Neurology at NYU School of
Medicine. "These studies show that Focalin XR may be an effective option for
both children and adults with ADHD. Furthermore, results of one of the
pediatric studies suggest that Focalin XR may be safe and effective in helping
to manage symptoms for as long as 12 hours."

Adult Study
The adult study was designed to evaluate the long-term efficacy, safety
and tolerability of Focalin XR 20 mg to 40 mg daily. The study was a 5-week,
multicenter, double-blind, randomized, placebo-controlled study followed by a
6-month open-label extension. Participants included 221 men and women aged 18
to 60 years who completed the 5-week double-blind clinical trial and 170
patients who continued into the 6-month open-label extension phase. All
subjects had a diagnosis of ADHD and the average age was 38.7 years. In the
double-blind study, the primary efficacy analysis compared the two higher
doses of Focalin XR (30 mg and 40 mg) versus placebo. The secondary efficacy
analysis compared the effects of Focalin XR 20 mg versus placebo. Efficacy
was measured using the Diagnostic and Statistical Manual-IV (DSM-IV) ADHD
Rating Scale, a standard assessment tool used in ADHD. Secondary measures
included evaluations rated by patients, clinicians and observers.
At the end of the double-blind study, Focalin XR was statistically
superior to placebo on both primary comparisons. The mean change from
baseline on the rating scale total score was significantly greater with all
doses of Focalin XR than with placebo. Score changes were 7.6 for placebo,
13.3 for patients taking the 20 mg dose of Focalin XR (P=.006), 12.9 for
patients treated with the 30 mg dose (P=.012) and 16.5 (P<.001) for patients
taking the 40 mg dose (all P values vs. placebo).
At the end of the open label extension, treatment response was evaluated
in 103 patients. Patients who switched from placebo to Focalin XR (n=20)
showed significant clinical improvement and patients continuing treatment with
Focalin XR (n=82) continued to show increasing benefits over six months, based
on changes in the DSM-IV ADHD Rating Scale.
Focalin XR was generally well tolerated. The most frequently reported
adverse events included headache, insomnia and decreased appetite.

Pediatric Studies
Data presented suggest that Focalin XR is safe and effective in the
treatment of children and adolescents with ADHD. One hundred three ADHD
patients aged 6 to 17 years participated in a double-blind, placebo-
controlled, parallel group study to compare the efficacy and safety of Focalin
XR to placebo. Efficacy was evaluated by examining the presence of ADHD
symptoms in school, home and clinical environments. In the study, the primary
outcome was measured by evaluating change from baseline using the Conners'
ADHD/DSM-IV Scales for Teachers (CADS-T). Secondary efficacy measures
included evaluations rated by teachers, parents and clinicians. At the end of
the study, the mean change from baseline on the CADS-T total subscale score
was 16.3 for Focalin XR and 5.9 for placebo (P<.001). Outcomes on all
secondary efficacy measures were also statistically significant in favor of
Focalin XR.
In a second pediatric study also presented at AACAP, investigators
evaluated the efficacy of Focalin XR 20 mg/day at various points throughout
the day up to 12 hours. The randomized, double-blind, crossover study
included 54 children aged 6 to 12 years with a DSM-IV diagnosis of ADHD who
were previously stabilized on methylphenidate 20 to 40 mg/day. Investigators
assessed improvement in attention and behavior among study participants in a
classroom setting at specific intervals for up to 12 hours post-dose.
Improvements were measured using the Swanson, Kotkin, Agler, Mylnn, and Pelham
(SKAMP) rating scale, a standard assessment tool used in clinical trials to
evaluate attention and behavior. Focalin XR was found to be significantly more
effective than placebo in treating ADHD symptoms, as measured by the SKAMP
rating scale, at each time point measured.
In both pediatric studies, Focalin XR was generally well tolerated.
Adverse events were consistent with those observed in other studies with
methylphenidate and dexmethylphenidate.
Focalin XR is an extended release form of the approved drug, Focalin
(dexmethylphenidate HCl). Focalin is an advance in single-isomer technology
and is formulated by isolating the active d-isomer of methylphenidate. Data
suggest that the d-isomer is responsible for the effective management of the
symptoms of ADHD. Focalin is available in 2.5, 5 and 10 mg tablets for oral
administration and may be administered with or without food.
Like most drugs approved for the treatment of ADHD, Focalin is
contraindicated in patients known to be hypersensitive to the drug or to
methylphenidate, in patients with glaucoma, and in patients with motor tics or
with a family history or diagnosis of Tourette's syndrome. It is also
contraindicated during treatment with monoamine oxidase inhibitors and also
within a minimum of 14 days following discontinuation of a monoamine oxidase
inhibitor (hypertensive crises may result). In addition, like most drugs
approved for the treatment of ADHD, Focalin is a schedule II drug and should
be given cautiously to patients with a history of drug dependence or

10.25.2004, 11:21 AM

Biotechnology company Celgene Corp. on Monday said three studies showed its extended-release capsules for attention deficit disorder drug Focalin XR were effective in children and adults, with one study showing results for 12 hours.

Celgene said an adult study of 221 participants, and a children's study of 103 participants showed the drug was superior to placebo. A second, 54-child study showed the drug continued to treat symptoms for as long as 12 hours.

The company, which licensed the worldwide rights to Focalin and Focalin XR to Swiss drug maker Novartis AG, excluding Canada, said Novartis submitted an application for the drug to the Food and Drug Administration, triggering a $7.5 million payment to Celgene.

A shorter-acting version of the drug is currently approved by the FDA for children and adolescents. Focalin and the longer-acting Focalin XR are refined versions of Ritalin.
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