Shire announced positive top-line results from two Phase 3 studies evaluating the efficacy and safety of Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) vs. placebo in adults with binge eating disordsers (BED).
Both studies were identically designed, multi-center, randomized, double-blind, parallel-group, placebo-controlled trials conducted in patients 18–55 years of age who met DSM-IV-TR criteria for a diagnosis of BED. Patients in study SPD489-343 (n=383) and study SPD489-344 (n=390) were randomized in a 1:1 ratio to Vyvanse or placebo. The primary efficacy endpoint was defined as the change from baseline to Weeks 11– 12 (Visit 8) in the number of binge days per week.
In both studies Vyvanse was found to be statistically superior to placebo on the primary efficacy analysis (P <0.001) of the change from baseline at weeks 11–12 in terms of number of binge days per week. The safety for Vyvanse in these two studies appeared to be consistent with the known profile established in studies in adults with attention-deficit/hyperactivity disorder (ADHD).
Vyvanse is already approved for the treatment and maintenance of ADHD in patients ≥6 years of age.
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