"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
|SOURCE Eli Lilly and Company|
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