October 17, 2005
Oscient Pharmaceuticals has announced positive results of phase III trials of Factive (gemifloxacin mesylate) tablets, for the treatment of acute bacterial sinusitis (ABS) and acute bacterial exacerbations of chronic bronchitis (AECB). Pooled retrospective results from their phase III ABS program indicated that Factive was significantly superiority to approved therapies (cefuroxime and trovafloxacin) in both clinical success at end of therapy (89.3% vs. 77%; p=0.01) and in clinical success at follow-up (79.9% vs. 66.3%; p=0.019). Pooled data from the company's 10 AECB trials indicated non-inferiority of clinical response compared to a number of approved therapies (including clarithromycin, levofloxacin, trovafloxacin, amoxicillin-clavulanate, ceftriaxone/cefuroxime and ofloxacin). Factive is currently approved to treat AECB and community-acquired pneumonia; in is still under investigation for ABS.