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
|SOURCE Novartis Pharmaceuticals Corporation|
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