Otsuka announces results from aripiprazole Phase 3 trial on schizophrenia

May 8 2012

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced results from a Phase 3 clinical trial evaluating the efficacy, safety and tolerability of once-monthly aripiprazole intramuscular (IM) depot formulation for the maintenance treatment of adults with schizophrenia. Trial results were presented in four poster presentations at the 2012 American Psychiatric Association (APA) Annual Meeting in Philadelphia.

The primary efficacy results are in press and will be published in the May 2012 issue of the Journal of Clinical Psychiatry (available online at http://dx.doi.org/10.4088/JCP.11m07530).

In a 52-week, double-blind, randomized, placebo-controlled study conducted by Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), aripiprazole IM depot formulation significantly delayed time-to-impending relapse compared to placebo, the primary endpoint of the study (Hazard ratio = 5.03, p<0.0001). In addition, improvements in the symptoms [as measured by the Positive and Negative Syndrome Scale (PANSS) total score] were maintained throughout the study in patients treated with aripiprazole IM depot formulation, while patients who received placebo reported significantly worsening scores (mean change from baseline at week 52 was 1.4 for aripiprazole IM depot formulation compared to 11.6 for placebo; LOCF analysis, p<0.0001).

"Otsuka and Lundbeck are committed to advancing care and addressing unmet needs for patients with schizophrenia," said William H. Carson, M.D., President and CEO, OPDC. "We are pleased to report positive data from the pivotal Phase 3 study designed to evaluate the efficacy, safety and tolerability of aripiprazole IM depot formulation as a long-term maintenance treatment for patients with schizophrenia."

"Long-term disease management is the ultimate goal of treating the nearly 2.2 million adults living with schizophrenia in the U.S.," said study investigator John M. Kane, M.D., Chairman of Psychiatry, The Zucker Hillside Hospital, and Vice President, Behavioral Health Services, North Shore-LIJ Health System. "Every relapse a patient experiences can cause further erosion of his or her mental and physical health. These study results demonstrate that a once-monthly injection of aripiprazole IM depot formulation is effective in delaying the time to relapse for patients with schizophrenia."

Commenting on the first data coming from the long-term alliance established between Otsuka and Lundbeck, Anders Gersel Pedersen, Executive Vice President and Head of Research & Development at Lundbeck added, "As two companies with deep expertise in central nervous system disorders, Otsuka and Lundbeck are tackling some of the most complex mental health conditions, including schizophrenia. The presentation of these data is the first of many steps we envision taking as a collaboration committed to advancing mental health drug development over the coming decade."