Vyvanse fails Phase III trials for Depression - Shire
Shire plc announced top-line results from two pivotal Phase III investigational studies evaluating the efficacy and safety of Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) versus placebo as an adjunctive treatment for Major Depressive Disorder (MDD) in adults who inadequately responded to antidepressant monotherapy with a SSRI or SNRI. Vyvanse did not meet the primary efficacy endpoint versus placebo for either study. The safety profile for Vyvanse in these two studies appears to be generally consistent with the known profile established in studies in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
Based on these clinical trial results, Shire will no longer pursue this clinical development program.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
3 mins