Oscient Completes Enrollment in Phase III Trial of Factive Tablets

Oscient Pharmaceuticals has completed enrollment in its pivotal Phase III clinical trial comparing a five-day treatment of Factive (gemifloxacin mesylate) tablets to the FDA-approved seven-day course of therapy for the potential treatment of community-acquired pneumonia of mild-to-moderate severity.

The noninferiority, double-blind study has enrolled over 460 patients at approximately 100 sites in the U.S. and Europe. The company expects to complete data analysis in the coming weeks, and pending the outcome of the analyses, the company plans to file a supplemental new drug application with the FDA for the indication by the end of 2005.