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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

- Focalin XR demonstrated better symptom control versus Concerta from 30

minutes to six hours post-dose in primary and secondary endpoints - Only Focalin XR provided onset of effect as early as 30 minutes post-dose - Additional analysis suggests Focalin XR provides comparable efficacy to

Concerta over 12 hours

- Symptoms of Attention Deficit/Hyperactivity Disorder (ADHD) can significantly impact a child's ability to focus and learn in an educational

setting

EAST HANOVER, N.J., July 8 /PRNewswire/ -- A head-to-head study, published in the June Journal of Child and Adolescent Psychopharmacology, confirms that Focalin(R) XR (dexmethylphenidate HCl) extended-release capsules offer greater improvements in managing symptoms of Attention Deficit/Hyperactivity Disorder compared with Concerta(R) (d,l- methylphenidate HCl) extended-release tablets at two hours post-dose, the primary study endpoint.

Focalin XR 20 mg and 30 mg2 also demonstrated better symptom control versus 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 Focalin XR 20 mg and 30 mg versus placebo. Neither dose of Concerta was effective versus placebo at 30 minutes. Novartis is seeking revised labeling to reflect the 30-minute onset of action.

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

Attention Deficit/Hyperactivity Disorder affects approximately three to seven percent of children in the United Stat
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SOURCE Novartis Pharmaceuticals Corporation
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