You are here

Positive Phase III Results Reported for Vyvanse (Lisdexamfetamine) in Adults With Binge Eating Disorder

Regulatory filing expected in 2014 (November 5)

Positive results have been reported from two identically designed randomized placebo-controlled phase III studies evaluating the efficacy and safety of Vyvanse (lisdexamfetamine dimesylate) capsules (CII) compared with placebo in adults with binge eating disorder (BED).

In both studies, lisdexamfetamine was found to be statistically superior to placebo (P

In addition to the positive primary results, both studies showed statistically significant (P

The drug’s developer (Shire Pharmaceuticals) plans to file for FDA regulatory approval of Vyvanse (lisdexamfetamine dimesylate) capsules for the treatment of BED in adults (18 to 55 years of age) by the third quarter of 2014. The drug is currently approved only for the treatment of ADHD in the U.S.

Source: Shire; November 5, 2013.

Recent Headlines

Drug With Androgen Deprivation Therapy Cut Risk of Death by 33% Compared With Placebo + ADT
A Diabetes Drug For People Without Diabetes
Roche Drug Outperformed Standard of Care in Phase 2 Study
U.S., Australia, and Canada Approve Endometrial Cancer Regimen
Single daily pill combines hypertension, cholesterol drugs
One in Five Kids’ Office Visits Results in an Off-Label Rx
Related Settlement Would End Many but Not All Lawsuits
Chronic Kidney Patients With Hyperphosphatemia May Be Another Market for the Drug
Nitrosamine Impurity Also Affects Other Ranitidine Drugs