FDA Approves First Drug for Binge-Eating Disorder
Vyvanse was approved under the FDA’s priority review program because of the limited treatment options available for this disorder.
In midwinter, Vyvanse—a medication originally approved for attention-deficit/hyperactivity disorder (ADHD)—became the first medication to be approved by the Food and Drug Administration (FDA) to treat binge-eating disorder.
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“Binge eating can cause serious health problems and difficulties with work, home, and social life,” said FDA Division of Psychiatry Products Director Mitchell Mathis, M.D. “The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating.”
Vyvanse was first approved in 2007 as a once-daily medication for ADHD in patients aged 6 and older. It is a Schedule II controlled substance because it has high potential for abuse and dependence. The active ingredient is lisdexamfetamine dimesylate.
According to the Agency for Healthcare Research and Quality, binge-eating disorder affects up to 2.5 percent of the population and has been recognized as a psychiatric disorder in DSM-5—the first time ever for such recognition in the Diagnostic and Statistical Manual of Mental Disorders.
“Cognitive-behavioral therapy is effective for treating patients with binge-eating disorder,” said Johns Hopkins Eating Disorders Program Director Angela Guarda, M.D., told Psychiatric News. “However, access to expert therapists trained in cognitive-behavioral therapy for binge-eating disorder is often limited, so there is a clear need for other effective treatments.”
The drug was reviewed under the FDA’s priority review program, which expedites the review process of drugs that are intended to treat serious conditions for which limited therapy options are available.
The FDA approved Vyvanse based on data generated from two clinical trials with 724 adults with moderate to severe binge-eating disorder. The results showed that 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 those taking placebo.
Adverse reactions reported by individuals taking Vyvanse included insomnia, increased heart rate, and anxiety. Results from one of the two studies—published in the January 14 JAMA Psychiatry—showed that 85 percent of participants taking the medication experienced some form of adverse reactions, compared with 59 in the placebo group.
Vyvanse’s medication guide notes the risks associated with the medication’s use, such as increased risk of psychotic or manic symptoms, including for individuals without a history of psychotic illness. The FDA emphasized that Vyvanse is not approved or recommended for weight loss.
“Because of the high rates of psychiatric and medical comorbidities associated in populations of people with binge-eating disorder, it is important to monitor the use of Vyvanse going forward,” said Guarda. “Long-term follow-up will be very important, with much focus on rates of remission and cessation of binge eating in patients treated with this agent.”
Vyvanse is marketed by Shire U.S. Inc. ■
An abstract of “Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-Eating Disorder” is posted at here.
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Published online: 3 March 2015
Published in print: February 21, 2015 – March 6, 2015
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