Alkermes, FDA Agree on Deal for Elements of ALKS 5461 Development Program

Alkermes plc ALKS today announced that it has successfully completed its End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), and the company plans to advance ALKS 5461 into phase 3 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 New Drug Application, the confirmatory study plans, the incorporation of innovative study designs that include the use of sequential parallel comparison design (SPCD), the primary endpoint and the statistical methodology. In September 2013, in advance of a planned End-of-Phase 2 meeting, Alkermes submitted a written briefing document detailing design elements of the proposed development program. The FDA's written responses aligned with the company's proposals such that the End-of-Phase 2 meeting was deemed unnecessary.