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Relmada Therapeutics announced the completion of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on its development program of REL-1017 (dextromethadone) for the adjunctive treatment of major depressive disorder (MDD) patients.
"Brexpiprazole, is a new option for patients with MDD who require augmentation therapy. Its unique mechanism of action and potential benefits will be a new source of optimism for patients suffering from Depression" said Dr. Diane McIntosh.
Alkermes’ ALKS 5461 has been hit with a potential setback in the US after regulatory advisors failed to back its approval for major depressive disorder (MDD).