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.
“The development of a three-month formulation of INVEGA SUSTENNA represents a first for the field of atypical antipsychotics and builds on Alkermes’ expertise in long-acting technologies,” said Dr. Elliot Ehrich, Chief Medical Officer at Alkermes. “Patients and physicians have a keen interest in new treatment options for schizophrenia. A three-month formulation of a long-acting atypical antipsychotic could significantly advance the treatment paradigm for schizophrenia, and we are looking forward to seeing the results from these phase 3 studies of INVEGA SUSTENNA.”
INVEGA SUSTENNA was approved as a once-monthly injectable medication for schizophrenia in the U.S. in 2009. It was also approved in the EU in 2011, where it is available under the trade name XEPLION ®. INVEGA SUSTENNA is marketed worldwide by the Janssen Pharmaceutical Companies. INVEGA SUSTENNA incorporates Alkermes’ proprietary technology for nanoparticles, and Alkermes earns a royalty on worldwide sales of the product.
Phase 3 ProgramTwo phase 3 studies of the three-month formulation of INVEGA SUSTENNA have been initiated and are expected to enroll approximately 1,800 patients with schizophrenia. The first study is a randomized, multicenter, double-blind, parallel-group, fixed-dose, relapse-prevention study and will explore the efficacy, safety and tolerability of the three-month formulation of INVEGA SUSTENNA, compared to placebo. Approximately 500 patients with schizophrenia will be enrolled in the study. The primary efficacy endpoint of the study is time to first relapse event during the double-blind phase.