Vyvanse (Lisdexamfetamine Dimesylate) Fails Phase III Studies in Adults With Major Depressive Disorder
Shire terminates clinical development program (February 6)
Disappointing results have been reported from two pivotal phase III trials 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 selective serotonin reuptake inhibitor (SSRI) or a serotonin–norepinephrine reuptake inhibitor (SNRI).
Vyvanse did not meet the primary efficacy endpoint versus placebo in either study.
Based on these results, the drug’s developer (Shire) will no longer pursue this clinical development program.
Vyvanse (lisdexamfetamine dimesylate) is currently approved only for the treatment of attention deficit hyperactivity disorder (ADHD) in the U.S.
Each of the two identically designed phase III, randomized, double-blind, parallel-group, placebo-controlled, dose-optimized studies was designed to assess the efficacy, safety, and tolerability of lisdexamfetamine dimesylate in patients aged 18 to 65 years who met DSM-IV-TR criteria for a diagnosis of MDD. The first study included 404 adults, and the second study included 426 adults.
The primary efficacy endpoint for the studies was defined as the change from augmentation baseline (week 8) to week 16 in the Montgomery–Asberg Depression Rating Scale (MADRS) total score. Lisdexamfetamine dimesylate did not meet the primary efficacy endpoint versus placebo for either study (P = 0.883 and P = 0.583).
Source: Shire; February 6, 2014.