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ICAAC: Antibiotic Factive (Gemifloxacin Mesylate) Eradicates Airway Infections More Quickly Than Biaxin (Clarithromycin) TORONTO, ON -- September 18, 2000 -- SmithKline Beecham's investigational antibiotic Factive® (gemifloxacin mesylate) eradicated the bacterium, H. influenzae, after one day of treatment in airway infections in patients with chronic bronchitis, according to data presented at the 40th Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) in Toronto. Factive is a highly active antibiotic with broad-spectrum activity against key respiratory pathogens. "Impressively, the bacteria were eradicated after just one day of treatment with just one dose of Factive," said Thomas File, MD, Professor of Internal Medicine at Northeastern University College of Medicine and Chief of Infectious Disease at Summa Health System (Akron, Ohio). "These results support the efficacy of 5-day treatment with Factive compared to seven-day treatment with Biaxin® in treating bacterial respiratory tract infections in patients with chronic bronchitis." A double blind, active-controlled study involving 709 patients compared the efficacy of five day treatment with Factive (320 mg once daily) to seven day treatment with Biaxin (clarithromycin) (500 mg twice daily) in patients with airway infections due to chronic bronchitis. For all patients with documented bacterial infections at study entry, the success rates with Factive were significantly better than the success rates with Biaxin in follow-up evaluation at week five (81.8 percent as compared to 62.0 percent, respectively). Bacterial eradication occurred on day one of treatment following one dose of Factive. In contrast, Biaxin-treated patients demonstrated evidence of H. influenzae persistence in patients through day seven. The results indicate that once-daily Factive taken for five days has significantly better bacteriological success rates and faster eradication of H. influenzae than Biaxin taken twice daily for seven days. "It is important to treat respiratory tract infections with an effective therapy that can eradicate bacteria quickly," commented Dr. File. "This study confirms that shorter treatment durations with Factive are effective in patients with chronic bronchitis." The most commonly reported adverse events were diarrhea (6.6 percent for Factive and 8.4 percent for Biaxin) and headache (6.3 percent for Factive and 8.7 percent for Biaxin). In vitro studies also presented at ICAAC demonstrate the high activity of Factive against resistant S. pneumoniae, H. influenzae and M. catarrhalis bacteria, which are the leading causes of respiratory tract infections. In one of these studies, Factive was found to be the most active antibiotic with broad-spectrum coverage compared to other antibiotics such as Levaquin® (levofloxacin) and Tequin® (gatifloxacin) against the multi drug-resistant bacteria S. pneumoniae, H. influenzae and M. catarrhalis. A separate study evaluated the activity of Factive, Levaquin, Avelox® (moxifloxacin) and Tequin, among others, against penicillin-resistant and multiple antibiotic-resistant S. pneumoniae. Factive retained activity against greater than 90 percent of isolates when the other drugs demonstrated reduced activity (71 percent for Avelox, 64 percent for Tequin and 16 percent for Levaquin). Community-acquired respiratory tract infections, such as bronchitis, pneumonia and sinusitis, are highly prevalent. In the United States, more than 15-20 million people are estimated to have chronic bronchitis, and patients with chronic bronchitis may have several cases of acute exacerbations of chronic bronchitis (AECB) per year. The American Lung Association (ALA) ranks chronic bronchitis among the top 10 most prevalent conditions in the United States. Respiratory tract infections are caused by several respiratory pathogens and are the most commonly treated infections in the United States. In fact, infections of the respiratory tract are some of the most common causes of morbidity and mortality globally and are the underlying cause of 30 out of every 100,000 deaths in the United States. The Factive New Drug Application was submitted in December of 1999 and is currently under review by the U.S. Food and Drug Administration. Factive had an extensive clinical trial program involving more than 9,000 patients to evaluate clinical efficacy and safety. Related Link: SmithKline Beecham. E-mail this page to a friend or colleague! To print, use this version