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Shire Plc Announces Positive Top-Line Results For Vyvanse In Adults With Binge Eating Disorder


Tuesday, 5 Nov 2013 02:06am EST 

Shire Plc announced positive top-line results from two identically designed randomized placebo-controlled Phase 3 studies evaluating the efficacy and safety of Vyvanse┬« (lisdexamfetamine dimesylate) Capsules (CII) versus placebo in adults with binge eating disorder (BED). In both studies Vyvanse was found to be statistically superior to placebo on the primary efficacy analysis (p-value <0.001) of the change from baseline at weeks 11 to 12 in terms of number of binge days per week. The safety for Vyvanse in these two studies appears to be generally consistent with the known profile established in studies in adults with Attention-Deficit/Hyperactivity Disorder (ADHD). In addition to the positive top-line primary results, both studies showed statistically significant (p-value <0.001) and consistent treatment effects for Vyvanse across the key secondary efficacy endpoints that have been analyzed thus far in the top-line data. These include the Clinical Global Impressions - Global Improvement (CGI-I), 4-week binge cessation, percent change from baseline in body weight, and change from baseline in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE).