Shire has announced top-line results from two pivotal Phase 3 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.
"While this news in major depressive disorder is disappointing for patients and Shire, we will later in the year be filing with the FDA for a new indication for Vyvanse in Binge Eating Disorder in adults, and Vyvanse is an effective and leading treatment for ADHD," said Flemming Ornskov, M.D., Shire's Chief Executive Officer. "We remain committed to serving patients with ADHD and will invest in solutions to meet their treatment needs accordingly. Shire's portfolio of treatments in rare diseases is also growing, strengthened recently with the acquisition of ViroPharma. Rare Diseases is an area of great unmet patient need and it's where we will increasingly focus our strategic development and investment."