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Alkermes plc (ALKS) Announces Advances With Its Late-Stage CNS Pipeline


1/8/2014 9:02:34 AM

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DUBLIN--(BUSINESS WIRE)--Alkermes plc (NASDAQ: ALKS) today announced new developments related to its late-stage product candidates in its proprietary central nervous system (CNS) pipeline. The company unveiled aripiprazole lauroxil two-month, a new product candidate addition to its portfolio of atypical antipsychotics for the treatment of schizophrenia. If approved, aripiprazole lauroxil two-month would be the first and only long-acting atypical antipsychotic medication dosed every two months. This new two-month product candidate is designed to provide physicians and patients with an even longer dosing option than the once-monthly formulation of aripiprazole lauroxil, which is currently completing the phase 3 study, with topline results expected in the first half of 2014. In addition, Alkermes provided details regarding its pivotal phase 3 program for ALKS 5461, a Fast Track-designated new medicine being evaluated for the treatment of major depressive disorder (MDD) in patients who have had an inadequate response to standard therapies. The phase 3 trials for ALKS 5461 will incorporate state-of-the-art study designs, and the pivotal program is expected to begin in the first quarter of 2014.

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