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Alkermes expects to use protection and efficacy data from the Forwards studies as the basis for a fresh Drug Software to become submitted to the U.S. Food and Drug Administration , pending study results. With a novel mechanism of actions and Fast Monitor designation from the FDA, ALKS 5461 is designed to offer a new treatment option for the millions of people with MDD with urgent unmet medical needs, mentioned Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. The extensive FORWARD program incorporates state-of-the-art design components for depressive disorder trials and will be carried out in collaboration with leading clinical investigators.