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Head-to-Head Study Demonstrates Focalin(R) XR Offers Faster and Better Symptom Control than Concerta(R)1 in Early Part of ADHD Patients' Day
Date:7/8/2008

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
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SOURCE Novartis Pharmaceuticals Corporation
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