The August issue of Respiratory Medicine reports two new studies evaluating the efficacy and safety of Oscient Pharmaceuticals' Factive (gemifloxacin mesylate) tablets for the treatment of community-acquired pneumonia (CAP) and acute bacterial exacerbations of chronic bronchitis (ABECB).

The studies compared Factive tablets to two commonly used antibiotics and measured clinical and bacteriological response at various time points post-therapy. The Factive product is a potent, broad-spectrum member of the fluoroquinolone class approved by the FDA for the treatment of CAP (of mild to moderate severity) and ABECB. Factive tablets are currently being introduced to healthcare providers, release from Oscient said.

The results appeared in first report - "A Randomized, Double-Blind Study Comparing 5 Days Oral Gemifloxacin with 7 Days Oral Levofloxacin in Patients with Acute Exacerbations of Chronic Bronchitis," authored by S Sethi, C Fogarty and A Fulambarker -showed clinical success with gemifloxacin (88.2 per cent) with only once-daily dosing for 5 days compared with once-daily dosing with levofloxacin for 7 days (85.1 per cent) at follow-up in the per protocol population, the study's primary endpoint.

Despite a shorter dosing regimen with gemifloxacin, the clinical success rates were similar between the two treatment groups in most analyses carried out in the study. The clinical success rates at long-term follow-up were 80.8 per cent for Factive tablets and 70.8 per cent for levofloxacin in the intent-to-treat population, a statistically significant difference. Factive treated patients experienced high rates of bacteriological eradication ranging from 75 per cent to 100 per cent for specific pathogens. The study also showed that Factive tablets and levofloxacin were safe and well-tolerated, although the withdrawal rate due to adverse events was lower with Factive tablets (2.2 per cent) than with levofloxacin (5.6 per cent).

"Our paper demonstrates the clinical utility of a potent antibiotic like gemifloxacin for the treatment of acute bacterial exacerbations of chronic bronchitis," Sanjay Sethi, associate professor of Medicine at the State University of New York at Buffalo, a co-author of the paper stated adding, "Factive tablets provide physicians with an efficacious, convenient, once-daily antibiotic for the treatment of ABECB. Factive tablets are a welcome addition to the treatment options available to healthcare providers."

Added Steven M Rauscher, president and CEO of Oscient Pharmaceuticals, "The expanding body of clinical evidence - now with over 200 articles published - continues to strengthen our understanding of the safety and efficacy of Factive tablets in treating community-acquired pneumonia and acute bacterial exacerbations of chronic bronchitis. Published data, like these articles, comparing our drug with similar products will provide the prescribing community with valuable information as to the potential use of Factive tablets for their patients."

A second study report demonstrated high rates of clinical success with a convenient once-daily Factive dosing regimen of only 7 days for patients with community-acquired pneumonia. Factive treated patients experienced a clinical success rate of 88.7 per cent. This success rate was similar to that reported for patients treated with a high dose, three times daily regimen of amoxicillin/clavulanate for 10 days (87.6 per cent). Further, Factive tablets eradicated 95.7 per cent of Streptococcus pneumonia clinical isolates obtained in the study, including those resistant to penicillin and macrolides. In this study, Factive tablets were well tolerated and there were significantly fewer withdrawals in the Factive group due to insufficient clinical response than in the amoxicillin/clavulanate arm (p=0.03).

These findings were reported in a second paper entitled, "Gemifloxacin Once Daily for 7 Days Compared to Amoxicillin/Clavulanic Acid Thrice Daily for 10 Days for the Treatment of Community-Acquired Pneumonia of Suspected Pneumococcal Origin," authored by P Leophonte, T File and C Feldman.