The study, which compared the five-day dosing (320mg once-daily) to the FDA-approved seven-day dosing, achieved its primary endpoint (non-inferior clinical response rate at the follow-up visit), illustrating the potential to utilize a short-course of Factive (gemifloxacin mesylate) to treat community-acquired pneumonia (CAP).
The double-blind study enrolled over 460 patients at approximately 100 sites in the US and Europe. Clinical response at follow-up in the per protocol population was 95% for the five-day treatment arm compared to 92% 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.
Oscient plans to submit these data for presentation at a major scientific conference in the fall and subsequently for publication in a medical journal. The company expects to file a supplemental New Drug Application with the FDA for the five-day treatment of CAP by the end of 2005.
“By demonstrating equivalent clinical response rates in this study for a five-day and a seven-day course of treatment with Factive, we have taken an important step toward bringing physicians and patients an effective and even more convenient option for treating community-acquired pneumonia,” stated Steven Rauscher, president and CEO of Oscient Pharmaceuticals.