FDA adds approved use for Shire's Vyvanse

SILVER SPRING, Md. — The Food and Drug Administration announced that it has expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults, making it the first FDA-approved medicine to treat this condition.

 

Patients with binge-eating disorder experience bouts of compulsive overeating, consuming larger amounts of food than what is normal. Patients also experience the sense that they lack control, the agency stated. Patients with the disorder will eat when they're not hungry — often to the point of being uncomfortably full. 

 

“Binge eating can cause serious health problems and difficulties with work, home, and social life,” said Mitchell Mathis, M.D., director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research. “The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating.”

 

Vyvanse — marketed by Shire U.S. — received FDA approval in 2007 as a once-daily medication to treat attention deficit hyperactivity disorder in patients ages 6 years and older. Because of the drug's high potential for abuse, it is categorized as a schedule II controlled substance.