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Children with ADHD experience greater reduction of symptoms with higher doses of Concerta...

June 03, 2004

PHOENIX, AZ (June 3, 2004) -- Children with attention deficit/hyperactivity disorder (ADHD) who take 36- or 54-mg doses of once-daily CONCERTA® (methylphenidate HCl) CII are more likely to achieve significantly greater symptom response and symptom reduction than children with ADHD who take CONCERTA 18 mg once daily or near-equivalent doses of methylphenidate three-times-a-day, a study shows.

"These results suggest that higher daily doses of CONCERTA may have greater therapeutic benefits in managing symptoms of children with ADHD that are not attained with lower doses of CONCERTA or with immediate release methylphenidate (IR MPH)," said study investigator George J. Wan, PhD, MPH, Director, Medical Affairs, McNeil Consumer & Specialty Pharmaceuticals. "Overall, CONCERTA was associated with clinically meaningful treatment response in approximately 70 percent of subjects. Higher doses of CONCERTA [36-54 mg once daily] produced significantly greater symptom response and remission rates," he added. The findings were presented at the New Clinical Drug Evaluation Unit meeting, a scientific conference sponsored by the National Institute of Mental Health.

About the Study A total of 282 children with ADHD, ages 6-12, participated in this randomized, multi-center, double-blind, placebo-controlled 28-day trial. Prior to randomization, subjects were assigned to dose levels based either on titration or conversion from previous MPH treatment. At 7:30 a.m., all children received CONCERTA (at either 18-, 36- or 54-mg) or IR MPH (5, 10, or 15 mg for a total daily dose of 15, 30, or 45 mg, respectively) or their corresponding matched placebos. At 11:30 a.m. and 3:30 p.m. children in the IR MPH group received the appropriate additional doses of IR MPH, whereas all others received placebo.

Response to therapy was measured by parent-rated IOWA Conners Inattention/ Overactivity (I/O) subscale. A clinically meaningful response to treatment was considered a >30% reduction from baseline IOWA Conners I/O score. Response rates were 69.2% for CONCERTA, 61.1% for IR MPH, and 21.4% for placebo (P < .0001; overall treatment comparison). These rates were 83.6% and 40% for CONCERTA dosages 36-54 mg (n=63) and 18 mg (n=31), respectively (P = .0001).

Subjects were considered to have achieved remission (no or minimal ADHD symptoms) when scores were reduced by >50%. Remission rates were 50.5% for CONCERTA, 36.7% for IR MPH, and 11.9% for placebo (P < .0001; overall treatment comparison). These rates were 62.3% and 26.7% for CONCERTA dosages 36-54 mg and 18 mg, respectively (P = .0018). No significant differences in response and remission rates were observed for IR MPH by dosage.
-end-
The study was sponsored by McNeil Consumer & Specialty Pharmaceuticals, U.S. marketers of CONCERTA.

About CONCERTA CONCERTA® (methylphenidate HCl) CII is a once-daily extended-release formulation of methylphenidate approved to treat ADHD. CONCERTA uses an advanced OROS® extended-release delivery system to deliver a controlled rate of medication throughout the day. Because of its unique OROS system, CONCERTA minimizes the ups and downs in blood levels experienced with stimulant medications taken several times a day.

CONCERTA should not be taken by patients with: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients in CONCERTA; glaucoma, Tourette's syndrome, tics, or family history of Tourette's syndrome; current/recent use of monoamine oxidase inhibitors (MAOIs). Abuse of methylphenidate may lead to dependence. CONCERTA should not be taken by children under 6 years of age.

In clinical studies with patients using CONCERTA, the most common side effects were headache, stomach pain, sleeplessness, and decreased appetite. For more information about CONCERTA, including full U.S. prescribing information, please visit www.concerta.net or call 1-888-440-7903.

CONCERTA® and OROS® are registered trademarks of Alza Corporation.

C2004-0102

Fleishman-Hillard, Inc.

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