Trials & Filings

Shire Drug Excels Against BED

ADHD treatment Vynase performs well in trials against binge-eating disorder

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

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 ...

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