Alkermes plc (ALKS) Release: INVEGA® SUSTENNA® Three-Month Formulation of Paliperidone Palmitate Enters Phase 3 Clinical Program for Schizophrenia
6/12/2012 10:28:58 AM
DUBLIN--(BUSINESS WIRE)--Alkermes plc (NASDAQ: ALKS) today announced that Janssen Research & Development, LLC has initiated a phase 3 clinical research program for a three-month formulation of INVEGA®SUSTENNA® (paliperidone palmitate), an injectable medicine for the treatment of schizophrenia. The investigational product is being developed by Janssen Pharmaceutica, NV, licensee to Alkermes’ proprietary technology for nanoparticles. Two phase 3 studies are expected to enroll approximately 1,800 patients with schizophrenia and will assess the efficacy, safety and tolerability of the three-month injectable formulation. These clinical studies are expected to be completed in the second half of calendar 2014.