Alkermes has successfully completed its End-of-Phase II interactions with the FDA, and the company plans to advance ALKS 5461 into Phase III development in early 2014. Alkermes is developing ALKS 5461 for the treatment of patients with major depressive disorder (MDD) who have inadequate response to standard therapies. The company and the FDA agreed on key elements of the development program, including preclinical and clinical requirements for the NDA, the confirmatory study plans, the incorpora...