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FDA Expands Use of Vyvanse (Lisdexamfetamine) to Include Treatment of Binge-Eating Disorder

Drug is CNS stimulant with potential for abuse, dependency

The FDA has expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate, Shire U.S., Inc.) to treat binge-eating disorder (BED) in adults. The drug is the first FDA-approved medication to treat this condition.

In BED, 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. BED 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, MD, 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 an expedited review of drugs that are intended to treat a serious disease or condition and that may provide a significant improvement over available therapy.

The efficacy of lisdexamfetamine in treating BED was demonstrated in two clinical studies that included a total of 724 adults with moderate-to-severe BED. In the studies, participants taking lisdexamfetamine experienced a decrease in the number of binge-eating days per week and had fewer obsessive-compulsive binge-eating behaviors compared with those receiving placebo.

Vyvanse is dispensed with a medication guide for patients, which provides important information about the medication’s uses 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, including lisdexamfetamine, may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a history of psychotic illness.

The most common side effects reported by subjects treated with lisdexamfetamine in clinical trials included dry mouth, insomnia, increased heart rate, jittery feelings, constipation, and anxiety.

Vyvanse is not approved 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 6 years of age and older. Vyvanse is a schedule II controlled substance because it has a high potential for abuse, with use of the drug potentially leading to dependence.

Source: FDA; January 30, 2015.

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