Vyvanse (lisdexamfetamine dimesylate) was approved by the U.S. Food and Drug Administration (FDA) on Friday as the first medication permitted to treat binge-eating disorder in adults.
“Binge eating can cause serious health problems and difficulties with work, home, and social life,” the FDA Center for Drug Evaluation and Research's Psychiatry Products Division Director Mitchell Mathis said.
Patients with binge-eating disorder have repeated episodes of irrepressible overeating. In such episodes, they eat large amounts and feel that they do not have control. Patients with the disorder eat when they are not hungry and in turn, experience uncomfortable fullness. Binge-eating often leads to weight gain, health problems linked to obesity and embarrassment in the patients.
“The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating,” Mathis said.
Vyvanse, by Shire U.S., Inc., was shown useful in treating binge-eating disorder through two clinical studies of 724 patients with binge-eating disorder. The patients who took Vyvanse had a reduction in binge-eating episodes compared to patients on the placebo.
The drug was assessed by the FDA’s priority review program. The review program was created to accelerate the examination of medications that treat serious diseases or conditions or could possibly offer improvements over existing therapies.