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Lurasidone Demonstrated Efficacy in Treating Patients With Schizophrenia in Pivotal Phase 3 Study
Date:8/26/2009

OSAKA, Japan, and FORT LEE, N.J., Aug. 26 /PRNewswire/ -- Dainippon Sumitomo Pharma Co., Ltd., (DSP) announced today positive results from PEARL 2 - a phase 3 clinical trial of lurasidone for the treatment of patients with schizophrenia. In this trial, both lurasidone 40 and 120 mg/day were significantly more effective than placebo for the treatment of schizophrenia. Lurasidone was well-tolerated with an overall discontinuation rate that was similar to placebo.

"We are pleased with the results of this study as these data reinforce our belief that lurasidone will be an important treatment option for patients with schizophrenia," said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co., Ltd. "We plan to submit our NDA filing package for lurasidone to the U.S. FDA in early 2010."

PEARL 2 (Program to Evaluate the Antipsychotic Response to Lurasidone) is part of an extensive worldwide phase 3 clinical development program, involving more than 2,000 patients, intended to evaluate the safety and efficacy of lurasidone for the treatment of schizophrenia. The PEARL 2 study was a double-blind, fixed-dose, placebo-controlled clinical trial involving 478 inpatients with acute schizophrenia that were randomized to receive either lurasidone 40 or 120 mg/day, olanzapine 15 mg/day or placebo for six weeks. The active comparator, olanzapine, was used for purposes of establishing assay sensitivity.

Lurasidone 40 and 120 mg, taken once-daily, demonstrated significantly greater improvement versus placebo on the primary efficacy measure, the Positive and Negative Syndrome Scale (PANSS) total score, at study endpoint. PANSS score changes from baseline for lurasidone 40 and 120 mg/day versus placebo were -25.7 and -23.6 vs. -16.0, respectively,
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SOURCE Dainippon Sumitomo Pharma Co., Ltd.
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