Overweight and obesity represent a continuum, and together are a chronic, complex, treatable disease. Emerging science on the regulation of hunger and satiety by the hypothalamus and other brain centers 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.
This month, the U.S. Food and Drug Administration (FDA) expanded the approved uses of Vyvanse® (lisdexamfetamine dimesylate) to include treatment of moderate-to-severe BED in adults, making it the first medication approved to treat this condition. Vyvanse® is marketed by Shire US, Inc.
“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® is a Schedule II controlled substance that initially was approved in 2007 as a once-daily medication to treat attention deficit hyperactivity disorder in patients ages 6 and older. The medication is not indicated or recommended for the treatment of obesity, according to a statement from Shire.
Efficacy Results in Clinical Trials
The efficacy of Vyvanse® in treating binge-eating disorder was shown in 2 12-week randomized clinical studies that included 724 adults with moderate-to-severe binge-eating disorder (ie, ≥3 binge days per week for 2 weeks prior to the baseline, and a Clinical Global Impression Severity score of ≥4 at baseline). Patients with current anorexia or bulimia nervosa, current comorbid psychiatric disorder, and cardiovascular risk factors other than obesity, and smoking were excluded from the studies.
In the studies, participants taking Vyvanse® experienced a significant decrease in the number of binge-eating days per week and had fewer obsessive-compulsive binge-eating behaviors compared to those taking placebo.
In study 1, Vyvanse® reduced the mean number of binge days per week from 4.79 at baseline to 0.78 at 12 weeks compared with a decrease from 4.60 to 2.22 in the placebo group. The least squares mean change from baseline in binge days per week was –3.87 and –2.51 for Vyvanse® and placebo, respectively. Similar findings were reported in the second study.
The most common side effects of Vyvanse® 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 23, 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 23, 2015.