FDA Approves the First Drug to Treat Binge Eating Disorder

The FDA HAS recently approved a new drug to treat binge eating disorder in adults. The amphetamine lisdexamfetamine dimesylate (Vyvanse®) was released under the FDA’s priority review program, which speeds approval of drugs that are intended to treat a serious disease or condition and that may provide a significant improvement over available therapy. The efficacy of Vyvanse in treating patients with BED was shown in two clinical studies that included 724 adults with moderate-to-severe BED. In both studies, participants taking the new product experienced a decrease in the number of binge-eating days per week and had fewer obsessive-compulsive binge eating behaviors compared to those on placebo. The drug is not new; it was first approved in 2007 as a once-daily medication for patients 6 years of age or older with attention deficit hyperactivity disorder, and it is a Schedule II controlled substance. The most common side effects reported in the clinical trials included dry mouth, insomnia, increased heart rate, jitteriness, constipation, and anxiety. Among the more serious side effects are sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants like lisdexamfetamine dimesylate may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness. Vyvanse is not approved for, or recommended for, weight loss.