Commencing a Phase 3b trial of daily oral medication ALKS 5461, Alkermes PLC will assess the treatment’s feasibility and safety for major depressive disorder patients with insufficient prior results obtained from other drugs.
Practitioners often recommend selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). In the hope that the medication can afford relief to individuals for whom these traditional prescriptions have failed, company representatives noted that ALKS 5461 features a unique action system.
“Opioid modulation represents a new mechanism for the treatment of depression that may provide benefits beyond those observed with traditional antidepressants,” said Dr. Elliot Ehrich, Alkermes executive vice president for research and development, noting that the firm anticipates a meeting with the Food and Drug Administration in July regarding the formulation.
The trial will evaluate results from as many as 325 patients over an 11-week period, using multiple populations in a randomized, double-blind placebo-controlled experiment. Results will be assessed using standard industry scales and measure efficacy, tolerance and safety. Alkermes considers the potential medication as an “adjunct” to treatment.
Global biopharmaceutical firm Alkermes develops medications to address central nervous system diseases. International operations are based in Dublin, Ireland, while U.S. headquarters are located in Waltham, Massachusetts.