Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced positive top-line results from a Phase 2 study to evaluate the safety and efficacy
(lisdexamfetamine dimesylate) Capsules, (CII) in adults with binge eating disorder
. Following discussions with the US Food and Drug Administration (FDA), Shire plans to conduct additional larger studies to confirm the validity of the findings.
The primary objective of the study was to evaluate the efficacy of 30, 50 or 70 mg of Vyvanse compared to placebo in the treatment of binge eating disorder at Week 11 as measured by the number of binge days per week as assessed by clinical interview based on patient diary. A binge day was defined as a day during which at least one binge episode occurred. The primary study end point was the change from baseline to Week 11 in log transformed (number of binge days per week + 1). Vyvanse 50 mg and 70 mg were statistically superior to placebo on the primary end point. Vyvanse 30 mg was not statistically superior to placebo on the primary end point, clarifying the dose range for future trials in this patient population.
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). Vyvanse should only be used to treat ADHD.
Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.