WASHINGTON — The U.S. Food and Drug Administration on Friday approved the stimulant lisdexamfetamine — Vyvanse, Shire — to treat binge-eating disorder, the first product to be approved for the condition.
Vyvanse is approved to treat attention deficit hyperactivity disorder.
Binge-eating disorder, characterized by repeated episodes of uncontrolled eating, accompanied by guilt and shame, affects roughly 2.8 million people in the United States, according to Shire.
“Binge eating can cause serious health problems and difficulties with work, home and social life,” Dr. Mitchell Mathis, director of the FDA’s division of psychiatry products, said. “The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating.”
In clinical studies, patients taking Vyvanse were shown to have significantly fewer binge days per week than those taking a placebo.
At the time of entry to the study, the average number of binge days per week was 4.79. At week 12, average binge days per week had fallen to less than one. Patients taking a placebo, by comparison, saw a reduction of little more than 2 days a week.
Vyvanse is an amphetamine, which, like other amphetamines, carries the potential for abuse and addiction. They also have been associated with increases in blood pressure and heart rate, sudden death, stroke, heart attack, insomnia and psychiatric side effects, such as hallucinations and mania.
The drug is not approved for weight loss.