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Title: Once-Daily Strattera (Atomoxetine) Effective in Children with Attention Deficit Hyperactivity Disorder: Presented at AACAP

"Once-Daily Strattera (Atomoxetine) Effective in Children with Attention Deficit Hyperactivity Disorder: Presented at AACAP"

By Paula Moyer Special to DG News SAN FRANCISCO, CA -- October 25, 2002 -- A new once-daily formulation of atomoxetine (Strattera), an investigative agent, appears to be a safe and effective for treatment of attention-deficit/hyperactivity disorder (ADHD). Dr. David Michelson, medical director of Lilly Research Laboratories in Indianapolis, Indiana, United States, and colleagues presented their data here October 24 at the 49th annual meeting of the American Academy of Child and Adolescent Psychiatry (ACAAP). "The once-daily formulation appears to be as effective as twice-daily atomoxetine treatment," said Dr. Michelson. "Treatment effects were seen into the evening, with dosing in the morning." Noting the universal popularity of once-daily dosing of treatments for a variety of conditions, Dr. Michelson and his colleagues conducted a randomised, double-blind, placebo-controlled study to assess the efficacy of this formulation of atomoxetine in children and adolescents, six to 16 years (average approximately 10 years), diagnosed with ADHD. The investigators randomised 85 children to treatment with once-daily atomoxetine and 86 to placebo. To evaluate response to treatment, they used the investigator-rated ADHD Rating Scale (ADHD-RS), the Conners' Parent Rating Scale-Revised (CPRS-R) and the Conners' Teacher Rating Scale-Revised (CTRS-R), as well as parent-rated diaries and Clinical Global Impressions of Severity (CGIS). Subjects in the atomoxetine arm had significantly superior outcomes to those in the placebo arm (p<0.001 for ADHD-RS). Treatment effect size (0.71) was similar to those observed in previous atomoxetine studies in which the twice-daily formulation was used. The parent diaries suggested that atomoxetine-specific effects were seen late in the day after a morning dosing. In both groups less than three percent of subjects discontinued due to adverse events. Dr. Michelson said his team observed no serious safety concerns. "These findings add to our knowledge about atomoxetine as an effective treatment for ADHD," he said. "We are continuing to study this medication." Atomoxetine differs from other ADHD medications because it is a norepinephrine reuptake inhibitor, rather than a stimulant. The study was funded by Eli Lilly, which received an approvable letter from the U.S. Food and Drug Administration for Strattera (atomoxetine) in April 2002.

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