Oscient Pharmaceuticals Corporation has completed enrolment in its phase IV post-marketing trial for its fluoroquinolone antibiotic, Factive (gemifloxacin mesylate) tablets. Known as the Force trial (FACTIVE Outpatient Respiratory Infection Community Experience).
Oscient began enrolment coincident with the launch of Factive in the fall of 2004. A commitment to complete post-marketing trials has become a condition of approval for many drugs and this trial was expected to take three to four years to complete. Patient enrolment at more than 200 clinical sites was completed nearly one year ahead of schedule, which allows for the submission of the study report to the FDA earlier than planned.
"By meeting our commitment to the FDA ahead of schedule, we reduce the total expense of the study and, following submission, our clinical development expenditures will decrease," stated Steven M Rauscher, president and CEO of Oscient Pharmaceuticals. "With more than one million patients treated worldwide, Factive is an important option for physicians treating serious lower respiratory tract infections."
The prospective, randomised study was designed to examine the safety of Factive in treating community-acquired pneumonia of mild to moderate severity (CAP) versus clarithromycin and in treating acute bacterial exacerbations of chronic bronchitis (AECB) versus amoxicillin/clavulanate in the community. Conducted in physician offices across the US, the trial enrolled more than 7,500 patients: approximately 5,000 in the Factive treatment group and approximately 2,500 in the comparator group. The study included patients of different ethnicities to gain additional safety information on populations not substantially represented in the clinical trial program.
Preliminary results observed to date are consistent with clinical trial results and pharmacovigilance data for Factive and have been submitted to the FDA through interim analyses. The company expects to submit the final study report to the FDA later this year.
Factive is approved in the US for the seven-day treatment of CAP and the five-day treatment of AECB. The FDA has established an action date of May 1, 2007 for the company's supplemental New Drug Application seeking approval for a five-day treatment of CAP.