Positive Phase III Results Reported for Vyvanse (Lisdexamfetamine) in Adults With Binge Eating Disorder
Regulatory filing expected in 2014 (November 5)
Positive results have been reported from two identically designed randomized placebo-controlled phase III studies evaluating the efficacy and safety of Vyvanse (lisdexamfetamine dimesylate) capsules (CII) compared with placebo in adults with binge eating disorder (BED).
In both studies, lisdexamfetamine was found to be statistically superior to placebo (P < 0.001) on the primary efficacy analysis of the change from baseline at weeks 11 to 12 in terms of the number of binge days per week. The safety of lisdexamfetamine in these two studies appeared to be generally consistent with the known profile established in studies in adults with attention-deficit/hyperactivity disorder (ADHD).
In addition to the positive primary results, both studies showed statistically significant (P < 0.001) and consistent treatment effects for lisdexamfetamine across key secondary efficacy endpoints. These endpoints included the Clinical Global Impression–Global Improvement (CGI-I) scale, 4-week binge cessation, the percent change from baseline in body weight, and the change from baseline in the Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCS-BE).
The drug’s developer (Shire Pharmaceuticals) plans to file for FDA regulatory approval of Vyvanse (lisdexamfetamine dimesylate) capsules for the treatment of BED in adults (18 to 55 years of age) by the third quarter of 2014. The drug is currently approved only for the treatment of ADHD in the U.S.
Source: Shire; November 5, 2013.