Alkermes plc (ALKS) Initiates Phase 3 Clinical Study of ALKS 9070 for Treatment of Schizophrenia
12/19/2011 6:08:52 AM
DUBLIN--(BUSINESS WIRE)--Alkermes plc (NASDAQ: ALKS) today announced the initiation of a phase 3 clinical trial of ALKS 9070 for the treatment of schizophrenia. ALKS 9070, a proprietary Alkermes molecule, is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY® for the treatment of a number of central nervous system (CNS) disorders. The multicenter, double-blind, placebo-controlled study is designed to assess the efficacy, safety and tolerability of ALKS 9070 in approximately 690 patients experiencing acute exacerbation of schizophrenia. The clinical data from this study, expected mid-calendar 2013, will form the basis of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ALKS 9070 for the treatment of schizophrenia, a chronic brain disease.