MedicalResearch.com Interview with:
Dr. Susan L. McElroy, M.D.
Professor of Psychiatry and Behavioral Neuroscience
Chief Research Officer
Lindner Center of HOPE
University of Cincinnati College of Medicine.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: SPD489-346, designed as a multi-center, double-blind, placebo-controlled, dose-optimized, randomized-withdrawal study, is the first-ever longer-term pharmacologic study (38 weeks) to evaluate the maintenance of efficacy between Vyvanse and placebo in adults with moderate to severe binge eating disorder (B.E.D.).
Study SPD489-346 evaluated the longer-term maintenance of efficacy (38 weeks) between Vyvanse and placebo based on the primary endpoint of time to relapse during the randomized-withdrawal phase in adults aged 18 to 55 (N=267) with moderate to severe B.E.D. based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition – Text Revision (DSM-IV-TR®) criteria. In the study, relapse was defined as having two or more binge days per week for two consecutive weeks prior to any visit and an increase in Clinical Global Impressions-Severity (CGI-S) score of two or more points relative to the randomized-withdrawal baseline visit
Results from SPD489-346 indicated that Vyvanse (n=136) demonstrated significant maintenance of efficacy compared to placebo (n=131) based upon the primary endpoint of time to relapse. At the conclusion of the study, maintenance of efficacy for patients who had an initial response during the open-label phase, and then continued on Vyvanse during the randomized-withdrawal phase, was demonstrated with Vyvanse being superior over placebo as measured by time to relapse.
Safety and tolerability evaluations of Vyvanse included treatment-emergent adverse events (TEAEs) and vital signs. The safety profile for Vyvanse in this study was generally consistent with the known profile reported in previous studies in adult patients with moderate to severe B.E.D.
Vyvanse is indicated for the treatment of moderate to severe B.E.D. in adults. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.
Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Vyvanse may harm others and is illegal.
MedicalResearch.com: What should readers take away from your report?
Response: The approval of Vyvanse as a treatment for adults with moderate to severe binge eating disorder offers a pharmacological treatment for appropriate patients. The development of treatment options for adults with B.E.D. is important to the adult patients who live with this complex disorder.
The data from SPD489-346 offer additional information to help health care professionals make informed treatment decisions for adult patients with moderate to severe B.E.D.
The longer-term maintenance of efficacy data in the updated Vyvanse labeling offer health care professionals additional information regarding Vyvanse as a treatment for appropriate adults with moderate to severe binge eating disorder.
MedicalResearch.com: Is there anything else you would like to add?
Response: Binge eating disorder (B.E.D.) is the most common eating disorder among adults in the U.S. compared to anorexia nervosa and bulimia nervosa. Binge eating disorder occurs in both men and women, and across different races and ethnicities. B.E.D. can occur in normal-weight, overweight or obese adults.
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