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FDA Approves Strattera(R) for Maintenance of ADHD in Children and Adolescents
Date:5/9/2008

First Medication Indicated for Maintenance Treatment for ADHD

INDIANAPOLIS, May 8 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) announced today that the United States Food and Drug Administration (FDA) has approved Strattera(R) (atomoxetine HCI) for maintenance treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA-approved non-stimulant 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, M.D., Associate Professor of Psychiatry, Harvard Medical School. "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 Strattera in the maintenance of ADHD was demonstrated in one of the largest relapse prevention studies ever conducted in ADHD, which is one of the most common mental health disorders in children and adolescents. (1)

The 18-month trial of about 600 children and adolescents aged six to 15 years, who met DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for ADHD, showed Strattera 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 Strattera had lower relapse rates (2.5 percent) as compared to patients taking placebo (12.2 percent).

Strattera provides uninterrupted relief from ADHD symptoms throughout the day into the evening. This is important since the symptoms of AD
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SOURCE Eli Lilly and Company
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