SOURCE: MPR
September 15, 2014
September 15, 2014
Shire announced that the Food and Drug Administration (FDA) has accepted for filing its supplemental New Drug Application (sNDA) with priority review for Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) for the treatment of adults with binge eating disorder (BED).
The sNDA submission was based on results from two identically designed randomized, placebo-controlled Phase 3 studies evaluating the efficacy and safety of Vyvanse vs. placebo. In both studies Vyvanse was found to be statistically superior to placebo on the primary efficacy analysis (P<0.001) of the change from baseline at weeks 11–12 in terms of number of binge days per week. The safety for Vyvanse in these two studies appeared to be consistent with the known profile established in studies in adults with attention-deficit/hyperactivity disorder (ADHD).
The sNDA submission was based on results from two identically designed randomized, placebo-controlled Phase 3 studies evaluating the efficacy and safety of Vyvanse vs. placebo. In both studies Vyvanse was found to be statistically superior to placebo on the primary efficacy analysis (P<0.001) of the change from baseline at weeks 11–12 in terms of number of binge days per week. The safety for Vyvanse in these two studies appeared to be consistent with the known profile established in studies in adults with attention-deficit/hyperactivity disorder (ADHD).
