To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ALA/ATS MEETING: Zyvox Appears To Eradicate Community-Acquired Pneumonia URL: http://www.pslgroup.com/dg/F9F62.htm Doctor's Guide April 28, 1999
SAN DIEGO, CA -- April 28, 1999 -- Phase II data on Zyvox™ (linezolid), the first of a new class of antibiotics, suggest that the compound is effective against community-acquired pneumonia (CAP) caused by Streptococcus pneumoniae, a gram-positive bacteria.
The results of the open label, Phase II clinical study data were presented today (April 28) at the American Lung Association/American Thoracic Society International Conference (ALA/ATS).
Zyvox is being developed by Pharmacia & Upjohn for the treatment of community-acquired pneumonia, as well as hospital-acquired pneumonia, skin and soft tissue infections and bloodstream infections all caused by gram-positive bacteria.
Zyvox comes from the oxazolidinone class, the first new class in more than 30 years, and has a unique mechanism of action that attacks bacteria before the initiation of the bacterial growth cycle, a point of action different from that of any other antibiotic currently available. The intravenous (IV) and oral formulations of Zyvox under development are both fully bioavailable.
Final results from the open-label Phase II dose comparison study show a combined microbiologic success rate of 96.4 percent at long-term follow-up (15-28 days after end of therapy) for the patients receiving either a high dose (N=38) or a low dose (N=18) of Zyvox. S. pneumoniae was the predominant organism identified in the patients. Other isolates included Staphylococcus aureus, Haemophilis species, and group B Streptococcus.
Of the 126 clinically evaluable patients in the study who received an average of nine days of therapy, 73 were microbiologically evaluable. Patients received either low dose (250 mg three times a day or 375 mg twice a day) or high dose (375 mg three times a day or 625 mg twice a day) regimens of Zyvox intravenously for at least three days and then were switched to oral treatment until the end of therapy.
The microbiologic success rate is based on the combined success rates for both dose levels excluding indeterminate. The clinical success rate for this study was 94.8 percent at long-term follow up.
Community-acquired pneumonia, a respiratory infection characterized by inflammation of the lungs, affects 4 million Americans each year, many are those who live together in interacting populations such as nursing homes, long-term care facilities and retirement homes. Common symptoms include fever, chills and a productive cough. Of these, from 500,000 to 1 million are hospitalized for treatment. This accounts for 10 percent of adult admissions to acute care hospitals in the United States annually, and the mortality rate for patients who suffer from severe CAP is 66 percent.
Overall, Zyvox appears to be well-tolerated. The most common drug-related medical events reported in the Phase II studies were headache, nausea and diarrhea that were usually mild to moderate in intensity.
"Zyvox has shown activity against all medically significant gram-positive bacteria tested and will have the benefit of IV and oral formulations that are fully bioavailable. The treatment of pneumonia in a hospital setting is a significant contributor to overall healthcare costs. Zyvox will allow patients to be discharged from the hospital on the same antibiotic treatment as that initiated in the hospital," said Melvin Morganroth, M.D., Clinical Associate Professor of Internal Medicine, Oregon Health Sciences University and Division Chief Critical Care, Providence Medical Center, Portland, Oregon. "This could significantly lower overall costs."
Last month, at the 9th European Congress of Clinical Microbiology and Infectious Disease in Berlin, Germany, Phase II data was presented suggesting the activity of Zyvox against complicated and uncomplicated skin and soft tissue infections caused by gram-positive bacteria. Data on the use of Zyvox in 273 patients showed a clinical success rate at long-term follow up of 93.2 percent.
Zyvox, now in Phase III clinical trials, is being studied for the treatment of community-acquired and hospital-acquired pneumonia, complicated and uncomplicated skin and soft tissue infections, and bacteremia caused by gram-positive bacteria, including methicillin-resistant Staphylococci (MRS), multi-resistant strains of S. pneumoniae and vancomycin-resistant enterococci (VRE). Zyvox is being developed in IV, tablet and oral suspension dosage forms and has demonstrated in vitro activity against gram-positive bacteria including those that are resistant to other antibiotics.
A New Drug Application (NDA) for Zyvox will be submitted in the United States after Phase III studies are completed and the results are analyzed. Pharmacia & Upjohn anticipates submitting registration applications for Zyvox by the end of 1999. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.