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Lurasidone Beats Placebo In Phase III, But Zyprexa Arm Could Confound

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Dainippon Sumitomo Pharma Co. has enough positive pivotal trials for its planned 2010 NDA filing for the atypical antipsychotic lurasidone, but newly released data from one of those trials reveal a discrepancy in the efficacy results that could be a hurdle at FDA.
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