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Back To Vidyya Newer Antibiotic May Shorten Hospital Stay

For Patients With Certain Hard-To-Treat Infections

Data presented this week during the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Toronto, Canada show Zyvox® (linezolid injection, tablets and for oral suspension) may help some patients with certain difficult-to-treat infections to be discharged from hospitals sooner.

Zyvox is the first antibiotic in a completely new class in 35 years that is an increasingly used option to treat indicated Gram-positive infections. Zyvox is being featured this week in a symposium, oral presentations and more than 40 posters at ICAAC.

A poster presented on Sunday, September 17 demonstrates that Zyvox is associated with a significantly higher rate of hospital discharge in the first week of therapy among patients with complicated skin and soft tissue infections (examples include surgical wound infections and serious abscesses).

To understand the impact of treatment with Zyvox on length of stay, researchers examined patterns of methicillin-resistant Staphylococcus (MRS) rates, which typically range from 20 to 50 percent in U.S. hospitals. The analysis compared length of stay for patients treated with Zyvox and patients treated with two other treatment regimens: vancomycin for MRS infections and oxacillin IV/dicloxacillin oral for methicillin-susceptible infections. In the group of patients where MRS infection rates were at or greater than 20 percent, as typically seen in a real world setting, the data indicate that discharge rates for clinically evaluable patients at day seven were significantly higher among patients treated with Zyvox than patients treated with comparators.

"Shorter hospital stays minimize costs and patient discomfort," said Jack Remington, M.D., Professor of Medicine at Stanford University Medical Center. "As data are presented and clinical experience is shared, we discover more about the efficacy, safety and convenience Zyvox affords healthcare professionals and patients."

Worldwide studies show Zyvox provides effective coverage of indicated Gram-positive infections, including susceptible and certain resistant infections. Zyvox is available in 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 was approved by the U.S. Food & Drug Administration on April 18, 2000, and is now available in the United States. Indications for Zyvox include the treatment of adults with complicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible and resistant), Streptococcus agalactiae and Streptococcus pyogenes. Representing the first antibiotic from the oxazolidinone class, Zyvox attacks bacteria in a way unlike any existing therapies. Zyvox attacks bacteria by stopping protein production at a very early point in the process that is different from any other antibiotic. Without protein production, bacteria cannot multiply and die.

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. Certain patients should have periodic monitoring of their blood platelet levels while taking Zyvox.

Zyvox is being developed for global use. In addition to the US, Zyvox has been approved in Brazil, Mexico and Chile. A New Drug Submission (NDS) was submitted to the Therapeutic Products Programme of Health Canada in November 1999 and is currently awaiting approval. A market authorization application has been submitted to the U.K. Medicines Control Agency (MCA), which is in the process of reviewing the file. A market application has been filed in Japan. Applications are also being submitted throughout Latin America and Asia.

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Editor: Susan K. Boyer, RN
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