Vyvanse Misses Endpoint in Major Depressive Disorder Trial
Shire announced results from two pivotal Phase 3 studies evaluating the efficacy and safety of Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) vs. placebo as an adjunctive treatment for major depressive disorder (MDD) in adults with inadequate response to antidepressant monotherapy with SSRI or SNRI.
Study SPD489-322 (n=404) and Study SPD489-323 (n=426) were two identically designed multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-optimized studies that assessed the efficacy, safety, and tolerability of Vyvanse in patients aged 18–65 years who met DSM-IV-TR criteria for a diagnosis of MDD. The primary efficacy endpoint for the studies was defined as the change from augmentation baseline (Week 8) to Week 16 in Montgomery-Ǻsberg Depression Rating Scale (MADRS) total score.
Vyvanse did not meet the primary efficacy endpoint vs. placebo for either study (P=0.883, P=0.583).
Results from Study SPD489-322:
- Subjects experienced a mean reduction of 6.1 in MADRS total score for Vyvanse compared with 6.3 for placebo.
- Augmentation baseline MADRS scores for Vyvanse and placebo groups were 25.4 and 25.2 respectively.
Results from Study SPD489-323:
- Subjects experienced a mean reduction of 7.3 in MADRS total score for Vyvanse compared with 6.8 for placebo.
- Augmentation baseline MADRS scores for Vyvanse and placebo groups were 26.0 and 25.7 respectively.
Vyvanse is already approved for the treatment and maintenance of ADHD.
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