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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

es, 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 (
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SOURCE Novartis Pharmaceuticals Corporation
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