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news.The Phase 2 study conducted by Shire reported that Vyvanse (lisdexamfetamine dimesylate) capsule, (CII) has met primary endpoint in adults with binge eating disorder.
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Vyvanse is a prescription medicine currently approved in the US and Canada, as well as in Brazil under the name Venvanse, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
The Phase 2 multi-centre randomised double-blind parallel-group placebo-controlled forced-dose titration study investigated the safety, efficacy and tolerability of Vyvanse 30, 50, or 70mg/day in 270 adults with binge eating disorder.
The study’s primary end point was the change from baseline to week 11 in log transformed (number of binge days per week + 1).
Shire Specialty Pharmaceuticals and Regenerative Medicine Businesses Research and Development senior vice president Jeffrey Jonas said the company plans to submit the data to the regulatory agencies for completing a clinical development program for Vyvanse as a treatment for patients suffering with binge eating disorder.
"After reviewing our data we will also explore opportunities for identifying biomarkers to aid in the diagnosis and treatment of patients with binge eating disorder," Jonas added.
Shire intends to conduct additional larger studies to confirm the validity of the Vyvanse data, following discussions with the FDA.