Vyvanse (Shire) success in Binge Eating Disorder studies

Shire plc has announced 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, being SPD 489-343 and SPD 489-343, Vyvanse was found to be statistically superior to placebo on the primary efficacy analysis (p-value <0.001) of the change from baseline at weeks 11 to 12 in terms of number of binge days per week. the safety for vyvanse in these two studies appears to be generally consistent with the known profile established in studies in adults with attention-deficit hyperactivity disorder.>

Additional analyses continue for other secondary endpoints. Shire anticipates presenting the efficacy and safety data from both studies at a major scientific meeting in 2014. The company plans to file for FDA regulatory approval of Vyvanse for the treatment of BED in adults (ages 18 to 55) by Q3 2014.