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FDA Approves Atomoxetine for Maintenance of ADHD in Children and Adolescents

INDIANAPOLIS -- May 9, 2008 -- The US Food and Drug Administration (FDA) has approved atomoxetine HCl (Strattera) for maintenance treatment of ADHD in children and adolescents. Atomoxetine, a selective norepinephrine reuptake inhibitor, is the first FDA-approved nonstimulant to treat ADHD in children, adolescents, and adults.

"The approval provides physicians and their patients with the first treatment option that is indicated for maintenance of ADHD," said Thomas J. Spencer, MD, Associate Professor of Psychiatry, Harvard Medical School, Boston, Massachusetts. "This is critical, as ADHD may be a life-long disease and effective long-term control of symptoms may mean improved outcomes in children and adolescents."

The safety and efficacy of atomoxetine in the maintenance of ADHD were demonstrated in an 18-month relapse prevention trial of 600 children and adolescents aged 6 to 15 years who met DSM-IV criteria for ADHD. Atomoxetine was superior to placebo in maintaining continuous efficacy in patients, as measured by the ADHD Rating Scale (ADHD-RS). Additionally, at the end of the trial, patients taking atomoxetine had lower relapse rates (2.5%) compared with patients taking placebo (12.2%).

The long-term, international, multicentre study, which was reviewed by the FDA as part of its decision to grant this approval, employed a treatment discontinuation design -- 3 months of acute open-label treatment followed by up to 15 months of placebo-controlled maintenance treatment -- that enabled investigators to test the efficacy of atomoxetine as maintenance therapy. In the study, 604 patients initially received acute open-label treatment with atomoxetine. After 10 weeks, 69% of patients qualified as responders and were re-randomised to double-blind treatment with either atomoxetine or placebo for 9 months. A second 6-month randomisation occurred after approximately 1 year of treatment, with 81 patients taking atomoxetine and 82 patients in the placebo group.

Results of both randomisation phases showed that patients treated with atomoxetine had significantly greater continuous response rates versus patients taking placebo. For child and adolescent ADHD patients with a good initial response to atomoxetine and who continued to respond well for 1 year, 97.5% maintained response on atomoxetine versus 87.8% on placebo (relapse rates: atomoxetine, 2.5%; placebo, 12.2%). Additionally, relapse rates for those discontinuing treatment after 1 year were lower than the relapse rates for patients who discontinued treatment during the 6 months following the open-label treatment phase (atomoxetine, 61/292 [20.9%]; placebo, 46/124 [37.1%]).

Atomoxetine was generally well tolerated. The most common side effects reported in the study were headache and nasopharyngitis. In the study, the mean final dose of atomoxetine was approximately 1.54 mg/kg/day after 12 months and 18 months of treatment. There were no significant differences in standardised height change between groups during the postrandomisation period.

SOURCE: Eli Lilly and Company

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