Oscient Achieves Primary Endpoint in Phase III Trial of Factive Tablets
Oscient Pharmaceuticals has completed preliminary data analysis of its pivotal Phase III trial examining the potential use of Factive (gemifloxacin mesylate) tablets for the five-day treatment of mild to moderate community-acquired pneumonia (CAP).
The study, which compared the five-day dosing (320 mg once-daily) to the FDA-approved seven-day dosing (320 mg once-daily), achieved its primary endpoint (non-inferior clinical response rate at the follow-up visit), illustrating the potential to utilize a short-course of Factive to treat CAP.
The double-blind study enrolled over 460 patients at approximately 100 sites in the U.S. and Europe. Clinical response at follow-up in the per protocol population was 95 percent for the five-day treatment arm, compared to 92 percent for the seven-day treatment arm, meeting the predefined statistical criterion for non-inferiority. No dose increase was needed in order to achieve non-inferiority with five days of therapy versus seven days. Additional endpoints included clinical response at end of therapy, radiological response at follow-up and bacteriological response at end of therapy and at follow-up.