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Equivalent Clinical Response Rates Seen in Short-Course Treatment of CAP With Gemifloxacin
"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 M. Rauscher, President and CEO of Oscient Pharmaceuticals. "Factive was sufficiently potent to allow treatment of patients for only five days with a high success rate. We plan to submit these data to the FDA by the end of 2005 and seek a label expansion for Factive. This would provide physicians with approved indications for treating both CAP and acute bacterial exacerbations of chronic bronchitis (AECB) with the same, convenient five-day course of therapy."
The double-blind study enrolled over 460 patients at approximately 100 sites in the United States and Europe. Clinical response at follow-up in the per protocol population was 95.0% for the five-day treatment arm compared to 92.0% for the seven-day treatment arm (95% CI: -1.46, 7.47), 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. Additional endpoints included clinical response at end of therapy, radiological response at follow-up and bacteriological response at end of therapy and at follow-up. The discontinuation rate due to adverse events in this trial was consistent with that seen in the pre-approval clinical trial program for the drug. The Company 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.
"We believe that a five-day course of therapy with Factive has the potential to improve patient compliance, decrease the risk of adverse events, reduce a patient's overall antibiotic exposure and possibly delay the development of resistance," added Mr. Rauscher.
There are an estimated three million cases of CAP each year resulting in approximately one million hospitalizations at a total cost of over $12 billion. FACTIVE was approved by the FDA for the treatment of mild to moderate CAP (caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae or Klebsiella pneumoniae) in seven days based on an extensive clinical trial program involving over 1,300 patients. In five clinical studies, including a pivotal trial versus amoxicillin/clavulanate, Factive demonstrated statistical non-inferiority to studied comparators. Factive is also approved for the treatment of mild to moderate CAP caused by multi-drug resistant Streptococcus pneumoniae.
Source: Oscient Pharmaceuticals Corporation