Alkermes announces initiation of study 217 for ALKS 5461 for treatment of MDD
Alkermes announced the initiation of study 217, a phase 3b trial of ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder. The study will evaluate the efficacy and safety of ALKS 5461 in patients suffering from MDD who have had an inadequate response to commonly prescribed drugs for depression, including selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors. In addition to the traditional Montgomery-Asberg Depression Rating Scale for assessing improvement in depression symptoms, study 217 will include scales to further evaluate ALKS 5461's potential benefits on mood and associated behavioral domains known to be regulated by endogenous opioid modulation. The company also reiterated plans to submit a New Drug Application for ALKS 5461 for the adjunctive treatment of MDD to the U.S. FDA by year-end 2017. Study 217 is a phase 3b, multinational, randomized, double-blind, placebo-controlled clinical trial that will evaluate the efficacy, safety and tolerability of ALKS 5461 as adjunctive treatment in patients with MDD. The 11-week, 2-stage study will randomize up to 325 patients and incorporates design features informed by the FORWARD pivotal program to help ensure rigorous patient selection, monitoring and evaluation. The primary objective of the study is to assess ALKS 5461's ability to improve depressive symptoms, as measured by MADRS-6 and MADRS-10. Specific scales to evaluate additional potential benefits of ALKS 5461 included in study 217 are the Connor-Davidson Resilience Scale, Snaith-Hamilton Pleasure Scale, Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, Brief Pain Inventory-Short Form, and the Clinical Global Impression-Severity and Clinical Global Impression-Improvement scales.