Shire Drug Excels Against BED

Shire has posted positive top-line results from two identically designed randomized placebo-controlled Phase III 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. The company plans to submit an sNDA for the BED indication to the FDA. Vynase is approved as a prescription treatment of ADHD.

Each of the two Phase III, multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-optimized trials was designed to assess the safety, efficacy, and tolerability of Vyvanse in patients aged 18 to 55 who met DSM-IV-TR criteria for a diagnosis of BED. One study randomized 383 patients and the other randomized 390 patients. Patients were randomized in a 1:1 ratio to Vyvanse or placebo. The primary efficacy endpoint for these studies was defined as the change from baseline to Weeks 11-12 (Visit 8) in the number of binge days per week determined by clinical interview based on participant diary data. Vyvanse was statistically superior to placebo on the primary efficacy analysis for both studies.

Safety and tolerability evaluations of Vyvanse included treatment-emergent adverse events (TEAEs), vital signs, weight, and electrocardiograms (ECGs). The key secondary endpoints analyzed to date included CGI-I, four-week binge cessation, percent change from baseline in body weight, and change from baseline in Y-BOCS-BE. The CGI-I was dichotomized as improved (including categories of ‘very much improved’ and ‘much improved’) or not improved (other categories excluding ‘not assessed’). The endpoint four-week cessation of binge eating is defined as no binge episodes for 28 consecutive days prior to the last study visit. The Y-BOCS-BE is a modified version of Yale-Brown Obsessive Compulsive Scale that measures the obsession of binge eating thoughts and compulsiveness of binge eating behaviors. Vyvanse was statistically superior to placebo on the key secondary efficacy endpoints analyzed to date for both studies.