FDA approves Shire’s Vyvanse to treat adults with binge-eating disorder

Vyvanse is the first and only medication approved for sale in the US for the treatment of this disorder.

The approval was based on results from two randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose-optimization trials which showed that binge-eating episodes reduced to an average of one day a week from five days a week, in patients who took Vyvanse capsules for 12 weeks, compared to those administered with a placebo.

Shire Research and Development global head Philip Vickers said: "Binge eating disorder is the most common adult eating disorder in the United States, and we are excited to provide the first FDA-approved treatment for moderate to severe B.E.D. in adults.

"This new indication for Vyvanse is a critical milestone in the treatment of this condition and reflects our ongoing commitment to address the needs of patients."

Currently, Vyvanse is approved to treat attention deficit hyperactivity disorder (ADHD) in patients six years of age or older.

University of Cincinnati College of Medicine professor of Psychiatry and Behavioral Neuroscience and and principal investigator of the B.E.D. clinical trials Susan McElroy said: "The management of B.E.D. is continuously being studied, and though advancements have been made to increase awareness and understanding of this real disorder, rates of diagnosis remain low.

"The development of new treatment options for adults with B.E.D. is important to the patients who continue to live with this complex disorder."

Image: Shire location in Lexington Massachusetts. Photo: courtesy of John Phelan.