FDA approves Strattera for ADHD in children and adolescents

May 8 2008

Eli Lilly and Company announced today that the United States Food and Drug Administration (FDA) has approved Strattera (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.

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 ADHD go beyond the work and school day. ADHD patients can experience frustration, low self-esteem, difficulty with relationships and increased lifestyle risks.

"In the past, our understanding of ADHD treatment was limited to clinical data on short-term use, meaning a few weeks or a couple of months," said A.J. Allen, M.D., Ph.D., Strattera global medical director for Eli Lilly and Company. "For the first time, clinicians have guidance that Strattera is effective for up to a year in patients who respond well to initial treatment."

The long-term, international, multi-center 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 Strattera as maintenance therapy. In the study, 604 patients initially received acute open label treatment with Strattera. After 10-weeks, 69% of patients qualified as responders and were re-randomized to double-blind treatment with either Strattera or placebo for nine months. A second six-month randomization occurred after approximately one year of treatment with 81 patients taking Strattera and 82 patients in the placebo group.

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

Strattera was generally well-tolerated. The most common side effects reported in the study were headache and the common cold (nasopharyngitis). In the study, the mean final dose of Strattera was approximately 1.54 mg/kg/day after 12 months and 18 months treatment. There were no significant differences in standardized height change between groups during the post-randomization period.