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
"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
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.