FDA Approves Drug for Binge Eating Disorder
The FDA approved lisdexamfetamine dimesylate to treat binge eating disorder in adults. This is the first FDA-approved medication to treat this condition. Lisdexamfetamine dimesylate, manufactured by Shire US, Inc, was reviewed under the FDA's priority review program.
"Binge eating can cause serious health problems and difficulties with work, home, and social life," said Mitchell Mathis, MD, director, division of psychiatry products, Center for Drug Evaluation and Research, FDA. "The approval of [lisdexamfetamine dimesylate] provides physicians and patients with an effective option to help curb episodes of binge eating."
The efficacy of lisdexamfetamine dimesylate for binge eating disorder was demonstrated in 2 clinical studies that included 724 adults with moderate to severe binge eating disorder. Participants taking lisdexamfetamine dimesylate experienced a decrease in the number of binge eating days per week and had fewer obsessive-compulsive binge eating behaviors compared with patients receiving placebo.
Binge eating disorder is the most common eating disorder among US adults, affecting an estimated 2.8 million US adults. It is more prevalent than anorexia nervosa and bulimia nervosa combined.
It was formally recognized as a distinct disorder in the new Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, which was released by the American Psychiatric Association in 2013.
The most adverse events associated with lisdexamfetamine dimesylate include psychiatric problems and heart complications, including sudden death in individuals who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants, including 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.
The most common side effects reported by people taking lisdexamfetamine dimesylate in the clinical trials included dry mouth, insomnia, increased heart rate, jittery feelings, constipation, and anxiety.
Lisdexamfetamine dimesylate is not approved for, or recommended for, weight loss. Its efficacy for weight loss has not been studied, according to the FDA.
The drug was previously FDA-appved in 2007 as a once-daily medication to treat attention-deficit/hyperactivity disorder ADHD in patients ≥6 years of age.
Lisdexamfetamine dimesylate is a schedule 2 controlled substance because it has high potential for abuse, with use potentially leading to dependence.—Kerri Fitzgerald
