Shire (SHPG) Announces Updated Vyvanse Labeling

October 17, 2016 7:02 AM EDT
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Shire plc (Nasdaq: SHPG) announces an update to the Vyvanse® (lisdexamfetamine dimesylate) labeling to include information regarding the approval of a supplemental New Drug Application (sNDA) by the U.S. Food and Drug Administration (FDA). The labeling will now include maintenance of efficacy data from SPD489-346, the first-ever longer-term pharmacologic study (38 weeks) in adults with moderate to severe binge eating disorder (B.E.D.). Results from SPD489-346, which were announced in July 2015, indicated that Vyvanse (n=136) demonstrated significant maintenance of efficacy compared to placebo (n=131) based upon the primary endpoint of time to relapse (p<0.001). Vyvanse is approved in the U.S. for adults with moderate to severe B.E.D. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.

"The FDA approval for the labeling update to include maintenance of efficacy data from the first-ever longer-term pharmacologic study in adults with moderate to severe B.E.D. advances our understanding of the efficacy and safety profile of Vyvanse for adults living with the disorder," said Philip J. Vickers, Ph.D., Global Head of Research and Development at Shire. "Collectively, the data and labeling update represent Shire's commitment to supporting patients and the health care community by expanding the growing body of research on B.E.D. with longer-term data in this disorder."

In the 26-week, double-blind, placebo-controlled, randomized-withdrawal phase of this 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. At the conclusion of the study, maintenance of efficacy for patients who had an initial response to Vyvanse during the open-label treatment 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. The safety profile for Vyvanse in this study, which evaluated treatment-emergent adverse events (TEAEs) and vital signs, was generally consistent with the known profile reported in previous studies in adult patients with moderate to severe B.E.D.

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is against the law.

"These data help health care professionals make more informed decisions when discussing treatment options for B.E.D. in adults," said Susan L. McElroy, M.D., Professor of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine. "Further, the updated Vyvanse labeling with this longer-term maintenance of efficacy data will offer health care professionals a better understanding of how the medication may be incorporated into broader treatment plans for adults with moderate to severe B.E.D."

Vyvanse is not appropriate for all adults with moderate to severe B.E.D. Adult patients who think they may have symptoms of B.E.D. should talk to their health care professional (HCP). Patients should work with their HCP to develop an appropriate treatment plan.



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