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| |  ECCMID: Zyvox (Linezolid) Effective For Pneumonia And Gram-Positive Bacterial Infections STOCKHOLM , SWEDEN -- May 30, 2000 -- Data from worldwide multi-center trials including European sites show Zyvox™ (linezolid injection , tablets and for oral suspension; Pharmacia Corporation) -- the first antibiotic from a new class in three decades -- is effective and generally well tolerated in the treatment of nosocomial (i.e. hospital-acquired) pneumonia, community-acquired pneumonia, uncomplicated and complicated skin and soft tissue infections caused by Gram-positive bacteria. Additional data suggest Zyvox may help contribute to shorter hospital stays for patients with soft tissue infections. These data were presented at the 10th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). Zyvox was approved by the U.S. Food & Drug Administration on April 18 and is now available in the U.S. Zyvox comes from a new class of antibiotics , the oxazolidinones. Worldwide clinical studies show Zyvox to be as effective as comparator antibiotics in treating certain infections caused by Gram-positive bacteria. European patients were represented in a multi-national trial that showed Zyvox may support earlier hospital discharge in the first week of therapy among patients with soft tissue infections caused by methicillin-resistant Staphylococcus species (MRSS) as compared to the patient group treated with vancomycin , due in part to Zyvox availability in both IV and oral formulations. Zyvox tablets are 100 percent bioavailable , meaning physicians can use the IV and tablet forms interchangeably without making a dose adjustment. "Zyvox is a truly unique antibiotic that has the potential to impact the way we treat Gram-positive infections in Europe," said Ragnar Norrby , M.D. , Professor , University Hospital , Lund , Sweden. "The safety profile and formulation flexibility of Zyvox are defining attributes that can potentially provide some patients the convenience to complete their treatment at home." Researchers at the meeting also presented data showing that Zyvox is a clinically effective treatment of Staphylococcal and Streptococcal skin and soft tissue infections and community-acquired pneumonia treated in the hospital , including infections caused by penicillin-resistant S. pneumoniae. In these studies , Zyvox was compared to current treatment options , including vancomycin , oxacillin/dicloxacillin , clarithromycin and ceftriaxone/cefpodoxime. Zyvox was shown to be as effective and well tolerated as these comparators. Based on clinical studies involving more than 4,000 patients , Zyvox is generally well tolerated. The adverse events reported for patients receiving Zyvox and comparators in clinical trials were similar. The most common events for patients treated with Zyvox were diarrhea (8.3 percent) , headache (6.5 percent) , nausea (6.2 percent) and vomiting (3.7 percent). Events were usually mild to moderate in intensity and limited in duration. Zyvox is being developed for global use. A market authorization application has been submitted to the UK Medicines Control Agency (MCA) , which is in the process of reviewing the file. Registrations in other European countries will follow. Applications are also being submitted throughout Asia and Latin America. Pharmacia Corporation is a leading global pharmaceutical company created through the merger of Pharmacia & Upjohn and Monsanto Company with its G.D. Searle & Co. unit. Pharmacia has a broad product portfolio , a robust pipeline of new drugs , and an annual investment of more than $2 billion in pharmaceutical research and development. Related Links: Zyvox (linezolid) and Pharmacia Corporation.
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