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Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data in Patients With Schizophrenia
Date:5/20/2009

arch program at the University of Cincinnati College of Medicine. "Lurasidone has the potential to be an important new therapeutic option for patients with schizophrenia."

Lurasidone's effect on weight was similar to placebo (median change 0.3 kg for overall lurasidone group vs. 0 kg for placebo) as was its effect on lipid and glucose measures. Lurasidone was also well tolerated with a lower overall discontinuation rate (31%) compared to placebo (43%) and few adverse event-related discontinuations (6% and 2% for the overall lurasidone group and placebo, respectively).

Adverse events seen in the trial were generally mild. The most commonly reported adverse events for lurasidone (greater than 5% and at least twice the rate of placebo) were akathisia (17.6% vs. 3.1% placebo), somnolence (11.7% vs. 5.5%), parkinsonism (6.8% vs. 0), and increased weight (5.1% vs. 2.4%).

"DSP is committed to the development of lurasidone and we look forward to the completion of our phase 3 clinical trial program and submission of a new drug application to the U.S. FDA," said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co., Ltd. "More importantly, we believe that lurasidone will be a valuable new treatment option for patients and physicians in addressing currently unmet needs in the treatment of schizophrenia."

"The development program for lurasidone is intended to establish efficacy for the core symptoms of schizophrenia, characterize its safety profile and explore its effects in the treatment of cognitive impairment and other areas not adequately addressed by current therapies," said Antony Loebel, M.D., vice president of clinical research, Dainippon Sumitomo Pharma America, Inc. "As a large, global trial, the PEARL 1 study is an important new addition to the existing clinical trial database."

PEARL 1 Study Design

This randomized, placebo
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SOURCE Dainippon Sumitomo Pharma Co., Ltd.
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