Shire announces new update to BED medication labeling

Vyvanse (lisdexamfetamine dimesylate) labeling has been updated to include information regarding the approval of a supplemental New Drug Application by the Food and Drug Administration (FDA). The labeling will now include maintenance of efficacy data from the first‐ever longer‐term pharmacologic study (38 weeks) in adults with moderate‐to‐severe binge eating disorder (BED), Shire officials announced. The data were presented at a few medical conferences including the Eating Disorders Association of Canada in September, and during the American College of Neuropsychopharmacology Annual Meeting a year ago. The updated labeling is based on a long‐term study showing that adults with moderate‐to‐severe BED who responded to Vyvanse were much more likely to stay in remission than if they stayed on placebo, Susan L. McElroy, M.D., professor of psychiatry and behavioral neuroscience at the University of Cincinnati College of Medicine, told CPU .