Feb 22 2007, 7:30 AM EST
News source: Business Wire
Oscient Pharmaceuticals Corporation's (Nasdaq: OSCI) fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin mesylate) tablets, is recommended, among other fluoroquinolones, for the treatment of patients with co-morbidities in the latest community-acquired pneumonia (CAP) consensus guidelines from the Infectious Diseases Society of American (IDSA) and the American Thoracic Society (ATS). Appearing as a supplement in the March 2007 issue of Clinical Infectious Diseases, the guidelines, titled "Infectious Diseases Society of America/American Thoracic Society Consensus Guidelines in the Management of Community-Acquired Pneumonia in Adults," outline the recommendations for treating CAP under several different conditions.
"This official statement of both the IDSA and ATS further illustrates an important role for FACTIVE, the most potent fluoroquinolone in vitro, in the physician's armamentarium," stated Steven M. Rauscher, President and Chief Executive Officer of Oscient Pharmaceuticals. "The new guidelines also highlight the concern over macrolide resistance in certain geographic areas and underscore the continued threat of bacterial resistance in treating respiratory infections."
The consensus guidelines highlight the best practices, based on scientific and clinical evidence, for the treatment of community-acquired pneumonia. The committee evaluated the utility of several different classes of antibiotics in treating CAP in making its recommendations. Among the recommendations are circumstances where respiratory fluoroquinolones, including FACTIVE, are suggested as first-line therapy in CAP. For example, in ambulatory CAP patients with co-morbidities, such as chronic heart, lung, liver or renal disease, diabetes, alcoholism, malignancies, immunosuppressing conditions or use of immunosuppressing drugs or previous antibiotic use (within three months), the guidelines suggest using a respiratory fluoroquinolone or a beta-lactam plus a macrolide. In addition, in geographic areas with a high prevalence of high-level macrolide-resistant Streptococcus pneumoniae, it is suggested that respiratory fluoroquinolones be used as first-line treatment, even in patients without co-morbidities. The guidelines also make the general recommendation to use the more potent drugs in a class first, as their use may help decrease the selection for antibiotic resistant bacteria.
FACTIVE is approved in the U.S. for the seven-day treatment of mild to moderate CAP, including CAP caused by multi-drug resistant Streptococcus pneumoniae, and the five-day treatment of acute bacterial exacerbations of chronic bronchitis. 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.
A link to the consensus guidelines is available on the IDSA website: www.idsociety.org.
About Oscient Pharmaceuticals
Oscient Pharmaceuticals Corporation is a commercial-stage biopharmaceutical company marketing two FDA-approved products with its national primary care sales force. ANTARA(R) (fenofibrate) capsules is indicated for the adjunct treatment of hypercholesterolemia (high blood cholesterol) and hypertriglyceridemia (high triglycerides) in combination with diet. FACTIVE(R) (gemifloxacin mesylate) tablets is an antibiotic approved for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. Oscient also has a novel, late-stage antibiotic candidate, Ramoplanin, under investigation for the treatment of Clostridium difficile-associated disease (CDAD).
For important information regarding the safety and use of ANTARA, please see the full prescribing information available at www.antararx.com.
Important Safety Information about FACTIVE Table
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