For Immediate Release
January 30, 2015
The U.S. Food and Drug Administration today expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition.
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.
“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 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.
The efficacy of Vyvanse in treating binge-eating disorder was shown in two clinical studies that included 724 adults with moderate-to-severe binge-eating disorder. In the studies, participants taking Vyvanse experienced a decrease in the number of binge eating days per week and had fewer obsessive-compulsive binge eating behaviors compared to those on the inactive pill (placebo).
Vyvanse is dispensed with a Medication Guide for patients, which provides important information about the medication’s use and risks. The most serious risks include psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants, like Vyvanse, may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness.
The most common side effects reported by people taking Vyvanse in the clinical trials included dry mouth, sleeplessness (insomnia), increased heart rate, jittery feelings, constipation, and anxiety.
Vyvanse is not approved for, or recommended for, weight loss. Its efficacy for weight loss has not been studied.
Vyvanse was approved in 2007 as a once-daily medication to treat attention deficit hyperactivity disorder in patients ages 6 and older. Vyvanse is a Schedule II controlled substance because it has high potential for abuse, with use potentially leading to dependence.
Vyvanse is marketed by Shire U.S., Inc., based in Wayne, Pennsylvania.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.