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.