Shire announces FDA approval of Vyvanse Capsules for binge eating disorder

Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) approved Vyvanse^® (lisdexamfetamine dimesylate) Capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults, shown to significantly reduce the mean number of binge days per week. Vyvanse is not indicated or recommended for weight loss or the treatment of obesity. Other sympathomimetic drugs used for weight loss have been associated with serious cardiovascular reactions.

"Binge eating disorder is the most common adult eating disorder in the United States, and we are excited to provide the first FDA-approved treatment for moderate to severe B.E.D. in adults," said Philip J. Vickers, Ph.D., Global Head of Research and Development at Shire. "This new indication for Vyvanse is a critical milestone in the treatment of this condition and reflects our ongoing commitment to address the needs of patients."

"The management of B.E.D. is continuously being studied, and though advancements have been made to increase awareness and understanding of this real disorder, rates of diagnosis remain low," said Susan L. McElroy, M.D., Professor of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine; and principal investigator of the B.E.D. clinical trials. "The development of new treatment options for adults with B.E.D. is important to the patients who continue to live with this complex disorder."

The efficacy of Vyvanse in the treatment of B.E.D. was demonstrated in two 12-week randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose-optimization studies in adults aged 18 to 55 years (Study 1: N=374, Study 2: N=350) with protocol-defined moderate to severe B.E.D. (severity was defined as having at least 3 binge days per week for 2 weeks prior to the baseline visit and a Clinical Global Impression Severity score of ≥4 at baseline). The primary efficacy outcome for the two studies was defined as the change from baseline at week 12 in the number of binge days per week. Baseline is defined as the weekly average of the number of binge days per week for the 14 days prior to the baseline visit.

Subjects from both studies on Vyvanse had a statistically significant greater reduction from baseline in mean number of binge days per week at Week 12. In study 1, Vyvanse reduced the mean number of binge days per week from 4.79 at baseline to 0.78 at study endpoint compared with 4.60 to 2.22 for placebo. The least squares mean change from baseline in binge days per week was -3.87 and -2.51 for Vyvanse and placebo, respectively. Similar results were seen in study 2.