“Binge eating can cause serious health problems and difficulties with work, home, and social life,” said FDA Division of Psychiatry Products Director Mitchell Mathis, M.D. “The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating.” The drug was reviewed under the FDA’s priority review program, which expedites the review process of drugs that are intended to treated serious conditions for which there are limited therapy options available.
The FDA approved Vyvanse based on data generated from two clinical trials with 724 adults with moderate-to-severe binge-eating disorder. The results showed that participants taking Vyvanse experienced a decrease in the number of binge-eating days per week and had fewer obsessive-compulsive binge-eating behaviors compared with those taking placebo. Most serious side effects reported by individuals taking Vyvanse included dry mouth, insomnia, increased heart rate, and anxiety.
Vyvanse's Medication Guide notes the risks associated with the medication's use, such as increased risk of psychotic or manic symptoms, even in individuals without a prior history of psychotic illness. The FDA emphasized that Vyvanse is not approved for, or recommended for, weight loss.
Vyvanse is marketed by Shire U.S. Inc.
View the FDA press announcement on Vyvanse. To read more about eating disorders and pharmacotherapies used to treat eating disorders, see the Psychiatric News article “Expert Hopeful About Future of Treatment for Eating Disorders.”