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Higher Once-Daily Doses of Concerta (Methylphenidate HCl) CII May Provide Greater Reduction of Behavioral Symptoms of Attention Deficit/Hyperactivity Disorder

SAN DIEGO, CA -- November 22, 2004 -- Children with attention deficit/hyperactivity disorder (ADHD) who take 36 to 54-mg doses of once-daily Concerta® (methylphenidate HCl) CII are more likely to achieve significantly greater reduction of behavioral symptoms associated with opposition and defiance than children with ADHD who take Concerta 18 mg once-daily or 5 to 15 mg of immediate release methylphenidate (IR MPH) three-times-a-day, research shows.

"The results of this study suggest that higher daily doses of Concerta may have greater therapeutic benefits than immediate release methylphenidate in managing some of the disruptive behaviors of children with ADHD," said study investigator George J. Wan, PhD, MPH, Director, Medical Affairs, McNeil Consumer & Specialty Pharmaceuticals. "Concerta 36- to 54-mg taken once-daily produced significantly greater symptom response," he added. The findings were presented at the 17th Annual U.S. Psychiatric and Mental Health Congress.

According to the Multimodal Treatment Study of Children with ADHD, 39.9% of children with ADHD have oppositional defiant disorder. Children with ADHD often express these behaviors in a number of different ways, such as a pattern of arguing with adults, losing their temper, refusing to follow rules, blaming others, deliberately annoying others, and being angry, resentful, spiteful, and vindictive.

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. Children received once-daily Concerta (at either 18-, 36- or 54-mg; n=95), IR MPH (5, 10, or 15 mg for a total daily dose of 15, 30, or 45 mg, respectively; n=97) or their corresponding matched placebos (n=90).

Symptom response to therapy was measured by parent- and teacher-rated IOWA Conners Oppositional/Defiant (O/D) subscales. The IOWA Conners O/D subscale was one of the primary endpoints assessed in this trial. A response to treatment was considered clinically meaningful if there was a greater than or equal to 30% reduction from baseline IOWA Conners O/D score. Parent response rates were 58.6% for Concerta, 52.3% for IR MPH, and 26.2% for placebo (P <.0001; overall treatment comparison). Furthermore, according to parent ratings, the proportions of responders were 77.2% and 23.3% for Concerta dosages of 36 to 54 mg and 18 mg, respectively (P<.0001) and were higher for Concerta dosages of 36 to 54 mg than for IR MPH dosages 5 to 15 mg (P<.05).

Overall, teacher-rated response rates were 67.6% for Concerta, 62.9% for IR MPH, and 43.1% for placebo (P =.0107; overall treatment comparison). 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 children using Concerta, the most common side effects were headache, stomach pain, sleeplessness, and decreased appetite. In clinical studies with adolescents using Concerta, the most common side effects were headache, accidental injury, and sleeplessness.

For more information about Concerta, including full U.S. prescribing information, please visit http://www.Concerta.net or call 1-888-440-7903.

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



SOURCE: McNeil Consumer & Specialty Pharmaceuticals

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