Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced today that an independent data monitoring committee (IDMC) has recommended the early termination of its Phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial. This is due to the study successfully meeting efficacy criteria at a protocol-specified interim analysis. The Aripiprazole Intramuscular Depot Study in Schizophrenia-U.S., evaluated the efficacy and safety of this investigational once-monthly IM depot formulation for the maintenance treatment of schizophrenia.
“The study successfully achieved its efficacy criteria ahead of schedule”
"The study successfully achieved its efficacy criteria ahead of schedule," said William H. Carson, M.D., President & CEO, OPDC. "According to the IDMC, the interim efficacy analyses met the pre-specified termination rules of the protocol."
Based on the successful interim analysis, OPDC anticipates filing a New Drug Application during fiscal year 2011. "This is an important milestone in our clinical development of aripiprazole," said Dr. Carson. "This will allow us to provide patients with schizophrenia in the U.S. another treatment option."
Otsuka Pharmaceutical Co., Ltd.