Topline Phase 2 Results Reported for Novel Antidepressant

Caroline Cassels

April 17, 2013

Positive, preliminary topline results from a phase 2 trial have been reported for ALKS 5461 (Alkermes PLC), a novel drug compound for treatment of resistant major depressive disorder (MDD).

According to the company, the drug "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."

Results from the 4-week, phase 2, randomized, double-blind, multicenter, placebo-controlled trial showed that when used as an adjunctive treatment with standard antidepressants, the drug significantly reduced depressive symptoms across a range of standard measures, including the study's primary outcome measures, which include the Hamilton Depression Rating Scale (P = .026), the Montgomery-Ǻsberg Depression Rating Scale (P = .004), and the Clinical Global Impression–Severity Scale (P = .035).

On the basis of these findings, the company reports that it plans to request a meeting with the US Food and Drug Administration and advance ALKS into a pivotal development program.

"The improvements in depressive symptoms observed in patients treated with ALKS in this study were clinically meaningful and could provide a valuable new treatment approach for this serious and chronic disease," study investigator Maurizio Fava, MD, said in a company press release.

"There is a significant unmet medical need for novel treatments with new mechanisms of action for depression, as many patients do not adequately respond to existing pharmacological therapies," Dr. Fava, who is director of the depression clinical and research program, Massachusetts General Hospital, and professor of psychiatry at Harvard Medical School in Boston, added.

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