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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

In addition to the positive primary results, both studies showed statistically significant (P

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.

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