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Study Demonstrating Lurasidone Is Effective in Patients With Schizophrenia Published in The Journal of Clinical Psychiatry
Date:6/3/2009

- Improvement Was Noted At Day 3 And All Subsequent Study Visits -

FORT LEE, N.J., June 3 /PRNewswire/ -- Dainippon Sumitomo Pharma Co., Ltd., (DSP) announced today that positive results from a phase 2 clinical trial for lurasidone in the treatment of patients with schizophrenia have been published in The Journal of Clinical Psychiatry. This six-week, randomized, double-blind, multicenter, placebo-controlled trial, involving 180 patients with acute schizophrenia, evaluated a single fixed dose of lurasidone 80 mg/day versus placebo. Lurasidone 80 mg/day produced statistically significant improvement versus placebo in both primary and secondary efficacy assessments at all study visits starting at day 3. In addition, lurasidone was generally well-tolerated and was associated with weight and metabolic changes that were similar to placebo. The study is available at www.psychiatrist.com.

"We are pleased to see the first publication reporting results of a lurasidone placebo-controlled trial in the treatment of patients with acute schizophrenia," said Antony Loebel, M.D., senior author and vice president of clinical research, Dainippon Sumitomo Pharma America, Inc. "Findings from this phase 2 study are consistent with data emerging from the lurasidone global development program, including a recently completed, large phase 3 placebo-controlled trial."

The primary efficacy measure was the BPRSd (Brief Psychiatric Rating Scale-derived). Lurasidone demonstrated significant improvement at Week 6 (LOCF endpoint) compared to placebo on the BPRSd (-8.9 vs. -4.2; p=0.012), as well as on all secondary efficacy measures, including the PANSS (Positive and Negative Syndrome Scale) total score (-14.1 vs. -5.5; p=0.004), PANSS positive subscale (-4.3 vs. -1.7; p=0.006), PANSS negative subscale (-2.9 vs. -1.3; p=0.025) and CGI-S (Clinical Global Impressions-Se
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SOURCE Dainippon Sumitomo Pharma Co., Ltd.
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