Alkermes Announces Positive Phase 2 Results from Clinical Study of ALKS 5461 for Major Depressive Disorder

Alkermes plc

today announced positive preliminary topline results from a phase 2 study of ALKS 5461, its novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression. ALKS 5461 reflects a new approach to the treatment of MDD based on modulation of opioid receptors in the brain and is designed as a non-addictive, oral, once-daily medicine. Data from the study showed that ALKS 5461 significantly reduced depressive symptoms across a range of standard measures including the study's primary outcome measure, the Hamilton Depression Rating Scale (HAM-D17) (p=0.026), the Montgomery–Åsberg Depression Rating Scale (MADRS) (p=0.004) and the Clinical Global Impression – Severity Scale (CGI-S) (p=0.035).