The U.S. Food and Drug Administration (FDA) recently expanded the approved uses of Vyvanse® (lisdexamfetamine dimesylate) to include treatment of moderate-to-severe binge-eating disorder (BED) in adults. It is the first medication to be approved to treat BED. Vyvanse® is a Schedule II controlled substance. The drug is marketed by Shire US, Inc.
What is binge-eating disorder?
BED is one of many types of eating disorders. People with BED frequently experience uncontrollable episodes of eating and afterward feel depressed, guilty and/or ashamed.
Overweight and obesity represent a continuum, and together are a chronic, complex, treatable disease. Emerging science on the regulation of hunger and feeling full by centers of the brain has helped to clarify how behavior (feeding) is biologically rooted. This knowledge has opened the door for new treatments to come to market for overweight and obesity.
“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.”
Clinical Trial Results
The effectiveness of Vyvanse® in treating BED was shown in two 12-week clinical studies that included 724 adults with moderate-to-severe binge-eating disorder. Study participants taking Vyvanse® had a significant decrease in the number of binge-eating days per week and had fewer obsessive-compulsive binge-eating behaviors compared to participants taking placebo.
The most common side effects reported in clinical trials included dry mouth, insomnia, decreased appetite, increased heart rate, jittery feelings, constipation, and anxiety.
American Society of Bariatric Physicians Applauded Approval of Vyvanse®
The American Society of Bariatric Physicians (ASBP) applauded the FDA’s decision to approve Vyvanse® to treat binge-eating disorder.
“Binge-eating disorder is one of the most common eating disorders within the obesity medicine community. Patients with binge-eating disorder often are affected by obesity and its co-morbidities, including type 2 diabetes, heart disease, sleep apnea, and some forms of cancer,” said Wendy Scinta, MD, Medical Director of Medical Weight Loss of New York, Fayetteville, New York, and Vice President of ASBP. “Despite valiant efforts at weight loss, if the binge-eating is not addressed, the patient is likely to gain the weight back. We are grateful to Shire for providing clinicians with another tool to use for long-term weight loss in this specialized population,” Dr. Scinta said.
“It’s important that we continue to develop options for obesity treatment. Each patient has a unique story and requires care personalized to meet his or her needs,” Dr. Scinta said.
American Society of Bariatric Physicians. FDA approval of Vyvanse® means more prescribing options for obesity medicine physicians. February 2, 2015. http://asbp.org/about/news/115-fda-approval-of-vyvanse-means-more-prescribing-options-for-obesity-medicine-physicians.html. Accessed February 24, 2015.
U.S. Food and Drug Administration. FDA News Release: FDA expands uses of Vyvanse® to treat binge-eating disorder. January 30, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm432543.htm. Accessed February 24, 2015.