Shire Gets FDA OK for Binge-Eating Drug
The US Food and Drug Administration has expanded the approved uses of Shire’s Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition.
Vyvanse was reviewed under the FDA's priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy. Vyvanse was approved in 2007 as a once-daily medication to treat attention deficit hyperactivity disorder in patients ages six and older. Vyvanse is a Schedule II controlled substance because it has high potential for abuse, with use potentially leading to dependence.
In binge-eating disorder, patients have recurrent episodes of compulsive overeating during which they consume larger amounts of food than normal and experience the sense that they lack control. Patients with this condition eat when they are not hungry and often eat to the point of being uncomfortably full. Patients may feel ashamed and embarrassed by how much they are eating, which can result in social isolation. Binge-eating disorder may lead to weight gain and to health problems related to obesity.