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US FDA Approves 30-Minute Onset of Action for Focalin(R) XR, Bringing Potential Benefits to ADHD Patients During Early Morning Period
Date:11/12/2008

et of action can help children with ADHD improve their morning academic productivity in school. Focalin XR also allows them to effectively manage their symptoms for up to 12 hours getting them through school and homework time," said Rafael Muniz, MD, Senior Medical Director, Novartis Pharmaceuticals Corporation.

Study Results

The data for 30-minute post-dose labeling includes a study by Brams et al. recently published in CNS Drugs. The study was a randomized, multi-center, double-blind crossover study in which participants received 20 mg of Focalin XR or placebo for seven days, with the final dose administrated in a laboratory classroom setting on the last day of each treatment period.

Primary efficacy was measured by the change from pre-dose in the Swanson, Kotkin, Agler, Mylnn, and Pelham (SKAMP) Rating Scale-Combined score at 0.5 hours, with additional secondary assessments at 1, 2, 4, 6 and 8 hours post-dose. The SKAMP rating scale is a standard assessment tool used in laboratory classroom clinical trials to evaluate attention and behavior.

Secondary efficacy was measured by the change from pre-dose at all time points in SKAMP-Attention and -Deportment, Math test-Attempted and -Correct scores, and change from baseline on the Conners' ADHD/DSM-IV Scale for Parents (CADS-P).

The overall rate of adverse events (AEs) was similar between groups (17.4% Focalin XR vs. 22.1% placebo). The most common AEs (>/= 2% patients during double-blind treatment) were abdominal pain, headache, increased appetite, and viral gastroenteritis. Most AEs were reported as mild (15% Focalin XR; 17% placebo) or moderate (1% Focalin XR; 5% placebo) in severity. One patient experienced a headache reported as severe while receiving Focalin XR. There were no serious AEs reported or discontinuations due to AEs.

Focalin XR (dexmethylphenidate HCl) extended-release capsules are indicated for the treatment of ADHD in adults, adolescents and children six yea
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SOURCE Novartis Pharmaceuticals Corporation
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