Atomoxetine approved by FDA for maintenance ADHD

May 12, 2008

Eli Lilly's ADHD drug Strattera is now indicated for long-term use.

Eli Lilly has announced the approval of a new indication for atomoxetine (Strattera). Following regulatory review, the Food & Drug Administration will now allow the drug to be marketed as a maintenance treatment for attention-deficit hyperactivity disorder (ADHD) in children and adults. According to the manufacturer, this marks the first time an ADHD medication has been indicated for maintenance treatment of the condition as prior clinical data were limited to short-term use. The approval was based on an 18-month trial of 604 patients ranging in age from six to 15 years who met the DSM-IV criteria for ADHD. Patients taking atomoxetine were more likely to maintain continuous efficacy as measured by the ADHD Rating Scale (ADHD-RS). Patients on atomoxetine also had lower relapse rates compared with patients taking placebo (2.5% vs. 12.2%). Atomoxetine is a selective norepinephrine reuptake inhibitor that is believed to control ADHD symptoms by blocking resorption of norepinephrine.

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