Alkermes recently announced the initiation of a phase 3b trial of ALKS 5461, an investigational once-daily, oral medicine that acts as a balanced neuromodulator, for adjunctive treatment of major depressive disorder.
“Opioid modulation represents a new mechanism for the treatment of depression that may provide benefits beyond those observed with traditional antidepressants. Along with the clinical community, we are looking forward to further exploring ALKS 5461’s potential in regulating domains such as social connection, resilience and anhedonia. Study 217 includes scales and endpoints to help elucidate ALKS 5461’s potential effects on these specific mood domains where opioid modulation may yield singular benefit,” Elliot Ehrich, MD, executive vice president of research and development at Alkermes, said in a press release. “In parallel, we plan to meet with the FDA in July for our scheduled pre-NDA meeting and are preparing our New Drug Application for ALKS 5461 for the adjunctive treatment of MDD.”
To assess efficacy and safety of ALKS 5461, researchers will conduct study 217, an 11-week, two-stage, multinational, randomized, double-blind, placebo-controlled clinical trial among up to 325 individuals.
The study’s primary endpoint will be improvement in depressive symptoms, measured by Montgomery–Åsberg Depression Rating Scale-6 and Montgomery–Åsberg Depression Rating Scale-10.
Additional assessments include 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.
Alkermes plans to submit a New Drug Application for ALKS 5461 as an adjunctive treatment for MDD by the end of 2017.