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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

Tuesday, July 8, 2008 General News J E 4
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EAST HANOVER, N.J., July 8 A head-to-head study, publishedin the June Journal of Child and Adolescent Psychopharmacology, confirms thatFocalin(R) XR (dexmethylphenidate HCl) extended-release capsules offer greaterimprovements in managing symptoms of Attention Deficit/Hyperactivity Disordercompared with Concerta(R) (d,l- methylphenidate HCl) extended-release tabletsat two hours post-dose, the primary study endpoint.

Focalin XR 20 mg and 30 mg2 also demonstrated better symptom controlversus Concerta 36 mg and 54 mg respectively, from 30 minutes to 6 hours.Symptom control was demonstrated as early as 30 minutes post-dose with FocalinXR 20 mg and 30 mg versus placebo. Neither dose of Concerta was effectiveversus placebo at 30 minutes. Novartis is seeking revised labeling to reflectthe 30-minute onset of action.

"There are many things to consider when determining which treatment isbest for a patient, including lifestyle implications," said Alice Mao, M.D.,Associate Professor of Psychiatry at the Baylor College of Medicine. "Theresults of this study demonstrate the benefits of Focalin XR during the earlypart of the day, which may be better for children who need their medication tobegin working before they leave for school and continue working throughout theday."

Attention Deficit/Hyperactivity Disorder affects approximately three toseven percent of children in the United States, and its symptoms-- inattention, hyperactivity and impulsivity -- can significantly impact achild's ability to focus and learn in an educational setting. The studyincluded children between the ages of 6 and 12 and examined their response toFocalin XR compared to Concerta as well as placebo in a classroom setting.

Similar efficacy was observed between Focalin XR and Concerta at eighthours post-dose. Only at 10 to 12 hours and 11 to 12 hours post-dose didConcerta 36 mg and 54 mg demonstrate symptom improvement over Focalin XR 20 mgand 30 mg respectively.

"Focalin XR helps children with ADHD optimize their natural cycle of theday because its drug delivery system allows for a quick onset in the morning,effective symptom management during the day, and then tapers off in theevening," said Rafael Muniz, MD, Senior Medical Director, NovartisPharmaceuticals Corporation.

Focalin XR uses the proprietary SODAS(R) (Spheroidal Oral Drug AbsorptionSystem) technology developed by Elan Corporation, where 50% of the dose isreleased immediately and the remaining 50% is released after approximatelyfour hours, resulting in a maximum peak at about 1.5 hours and a second peakat about 6.5 hours. Concerta is formulated to release 22% of the druginitially, with the remainder released through a controlled osmotic process.

In addition, Focalin XR and Concerta have chemical differences. Focalin XRisolates the active d-isomer of d,l-methylphenidate. Therefore, only half thedose of methylphenidate is required. Concerta is a d,l-methylphenidate.

Study Results

The randomized, multi-center, double-blind, five-period, crossover studywas conducted in 84 children with ADHD with 6-12 years of age, stabilized onmethylphenidate and randomized to different treatment sequences forcomparison. The study was conducted in a laboratory classroom setting over a12 hour period. The crossover design exposed each child to five treatments:Focalin XR (20 mg/day and 30 mg/day), Concerta (36 mg/day and 54 mg/day) andplacebo.

Primary efficacy was measured by the change from pre-dose in the Swanson,Kotkin, Agler, Mylnn, and Pelham (SKAMP) Rating Scale-Combined scores at twohours post-dose with Focalin XR 20 mg compared with Concerta 36 mg. The SKAMPrating scale is a standard assessment tool used in laboratory classroomclinical trials to evaluate attention and behavior.

Both doses of Focalin XR showed significantly greater improvement inSKAMP-Attention and -Depo
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