Shire demonstrates efficacy of ADHD drug for binge eating

Ireland-headquartered drugmaker Shire (LSE: SHP) has announced top-line results from two identically designed randomized placebo-controlled Phase III studies evaluating the efficacy and safety of Vyvanse (lisdexamfetamine dimesylate) capsules in adults with binge eating disorder (BED).

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 (ADHD). The drug in its current indications generated sales of $897.9 million in the first nine months of 2013.

Flemming Ornskov, chief executive of Shire, said: “We are extremely pleased with these results, and will be working expeditiously to submit an application to the US Food and Drug Administration for a new indication of BED for Vyvanse, already well-established for its efficacy and safety in ADHD. BED is a condition for which there is no currently approved pharmacologic treatment and yet there is significant unmet patient need, as was demonstrated with the faster than expected enrollment of participants in our clinical trial program. Our development of Vyvanse for BED also aligns well with Shire’s growth strategy of developing innovative treatments to address significant unmet patient needs.”