ADHD Drug Now Approved to Treat Binge-Eating Disorder
Shire's lisdexamfetamine dimesylate (Vyvanse) today became the first and only FDA-approved medication to treat binge-eating disorder in adults.
Shire’s lisdexamfetamine dimesylate (Vyvanse) today became the first and only FDA-approved medication to treat binge-eating disorder in adults, following the FDA’s inclusion of the disease in the drug’s approved uses.
Vyvanse was first approved in 2007 as a once-daily treatment for attention deficit hyperactivity disorder in patients aged >6 years. A supplemental New Drug Application to include binge-eating disorder in the drug’s indication was granted priority review status by the FDA in September 2014.
The FDA’s decision to expand Vyvanse’s indication was based on the results of 2 clinical trials evaluating the drug’s efficacy in 724 adults with moderate-to-severe binge-eating disorder. The research team found that Vyvanse was associated with a decrease in binge eating days per week and obsessive-compulsive binge eating behaviors compared with placebo.
“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, in a press release. “The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating.”
The most common adverse events reported by trial participants given Vyvanse included dry mouth, sleeplessness (insomnia), increased heart rate, jittery feelings, constipation, and anxiety.