It’s the first drug sanctioned in the United States to treat the disorder, the agency said in a news release. Vyvanse was first approved in 2007 to treat attention-deficit/hyperactivity disorder for those aged 6 and older.
Vyvanse’s safety and effectiveness in treating binge-eating disorder were evaluated in clinical studies involving 724 people. Compared to participants taking a placebo, those taking Vyvanse experienced a decrease in the number of binge eating days per week and reported fewer obsessive-compulsive binge eating behaviors.
A central nervous system stimulant, Vyvanse could cause serious complications, including stroke and heart attack. It also could cause sudden death among users with heart problems, the FDA said. Less serious side effects could include dry mouth, insomnia, increased heart rate, constipation, anxiety, and feeling jittery.
The drug is marketed by Shire U.S., based in Wayne, Pa.
FDA News Release. FDA expands uses of Vyvanse to treat binge-eating disorder. January 30, 2015.