WASHINGTON (dpa-AFX) - Alkermes plc (ALKS) Wednesday revealed positive preliminary topline results from a phase 2 study of ALKS 5461, its novel drug compound for major depressive disorder or MDD in patients who have an inadequate response to standard therapies for clinical depression. The company said ALKS 5461 significantly reduced depressive symptoms across a range of standard measures including the study's primary outcome measure, the Hamilton Depression Rating Scale, the Montgomery-Åsberg Depression Rating Scale and the Clinical Global Impression - Severity Scale.
Alkermes further said ALKS 5461 was well tolerated in the study. Based on these results, as well as the positive phase 1/2 results previously reported, Alkermes plans to request a meeting with the U.S. Food and Drug Administration and advance ALKS 5461 into a pivotal development program.
Commenting on the development, Maurizio Fava, Director of the Depression Clinical and Research Program at Massachusetts General Hospital said, 'The improvements in depressive symptoms observed in patients treated with ALKS 5461 in this study were clinically meaningful and among the most robust I have seen in a phase 2 study for depression in the past two decades. This promising candidate could provide a valuable new treatment approach for this serious and chronic disease...'
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