FDA Okays Vyvanse for Binge Eating Disorder
by Caroline Cassels, mEDSCAPE
January 30, 2015
The US Food and Drug Administration (FDA) has approved lisdexamfetamine dimesylate (Vyvanse, Shire) to treat binge eating disorder (BED) in adults. The drug is the first FDA-approved medication to treat this condition.
"Binge eating can cause serious health problems and difficulties with work, home, and social life," said Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating."
Vyvanse was reviewed under the FDA's priority review program, which provides for an expedited review 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 BED was shown in two clinical studies that included 724 adults with moderate to severe BED, as reported by Medscape Medical News. In the studies, participants taking Vyvanse experienced a decrease in the number of binge eating days per week and had fewer obsessive-compulsive binge eating behaviors compared with patients in a placebo group.
The most common eating disorder among adults in the US, BED affects an estimated 2.8 million US adults and 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, Fifth Edition, which was released by the American Psychiatric Association in 2013.
Vyvanse is dispensed with a medication guide for patients, which provides important information about the medication's use and risks. The most serious risks 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, such as Vyvanse, 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 Vyvanse in the clinical trials included dry mouth, sleeplessness (insomnia), increased heart rate, jittery feelings, constipation, and anxiety.
Vyvanse is not approved for, or recommended for, weight loss. Its efficacy for weight loss has not been studied, the FDA notes.
In 2007, the drug was approved by the FDA as a once-daily medication to treat attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older. Vyvanse is a Schedule II controlled substance because it has high potential for abuse, with use potentially leading to dependence.