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.
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