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Shire plc Message Board

  • blackoutbuzz blackoutbuzz Nov 5, 2013 10:14 AM Flag

    Vyvnase treats binge eating disorder

    Per wikiepedia, roughly 5.5% of USA population is affected...seems like a significant pontential addressable market

    @@@@@3:29AM Shire plc reports positive results shown for Vyvanse in adults with eating disorders (SHPG) 134.98 : Co announces announces positive top-line results from two identically designed randomized placebo-controlled Phase 3 studies evaluating the efficacy and safety of Vyvanse Capsules versus placebo in adults with binge eating disorder. In both studies Vyvanse was found to be statistically superior to placebo on the primary efficacy analysis 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. The Company is reporting the data sooner than originally anticipated because of faster than expected completion of both studies.In addition to the positive top-line primary results, both studies showed statistically significant and consistent treatment effects for Vyvanse across the key secondary efficacy endpoints that have been analyzed thus far in the top-line data. 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.