Alkermes Aligns with FDA for Development Plans

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 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 II 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 II meeting was deemed unnecessary, according to Alkermes. The company plans to begin ALKS 5461’s Phase III program in early 2014.