5th Nov 2013 07:53
SAINT HELIER (Alliance News) - Shire PLC. Tuesday reported positive top-line results from two Phase 3 studies evaluating the efficacy and safety of Vyvanse or lisdexamfetamine dimesylate capsules placebo in adults with binge eating disorder. Vyvanse was found to be statistically superior to placebo on the primary efficacy analysis, and safety data also is consistent with the known profile established in studies in adults with Attention-Deficit or Hyperactivity Disorder.
Additionally, the company said the trials showed significant and consistent treatment effects for Vyvanse across the key secondary efficacy endpoints that have been analyzed so far in the top-line data, including Clinical Global Impressions - Global Improvement, 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. Shire expects to file for FDA approval of Vyvanse by third quarter of 2014.
Vyvanse is a prescription medicine currently only approved for the treatment of ADHD in the United States, Canada, Australia, several European countries.
Copyright RTT News/dpa-AFX
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