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| |  IDSA: New Antibiotic Zyvox Effective For Gram-Positive Bacterial Infections PHILADELPHIA, PA -- November 22, 1999 -- A recent analysis of data collected during several, large Phase III clinical trials for Zyvox™ (linezolid), an investigational new antibiotic under development by Pharmacia & Upjohn, evaluated the safety of Zyvox in the treatment of infections caused by Gram-positive bacteria. The incidence of all individual drug-related adverse events in patients treated with Zyvox and patients treated with active comparators was low (less than five percent). These data were discussed today at the 37th Annual Meeting of the Infectious Disease Society of America (IDSA). Phase III data presented included summaries of adverse events for 2,046 patients treated with Zyvox and pooled results for 2,001 patients treated with active comparators. The most common side effects reported for patients treated with Zyvox were similar in incidence and severity to the most common side effects reported for patients treated with commonly used antibiotics selected as the active comparators in the trials. The most frequent drug-related adverse events in both the group treated with Zyvox and the group treated with comparators included mild to moderate diarrhea, nausea and headache, which each occurred in 5 percent or less of patients in both groups. The comparators included ceftriaxone and cefpodoxime proxetil (cephalosporins); dicloxacillin and oxacillin (beta-lactams); clarithromycin (a macrolide); and vancomycin (a glycopeptide). "The safety profile for Zyvox is promising," said Robert Moellering, MD, Physician-In-Chief and Chairman, the Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts and IDSA session faculty member. "There is currently a very real clinical need for a well-tolerated antimicrobial available in both IV and oral formulations that is effective against Gram-positive bacteria that are resistant to currently licensed drugs. Such a medication in both IV and oral formulations would help ensure that patients could complete their course of therapy in the most convenient way possible." Zyvox has been developed in both IV and oral formulations. The oral formulation is 100-percent bioavailable, meaning no dose adjustment was necessary when switching from IV to oral dosing in clinical trials. Phase III clinical trial data released in September suggested that Zyvox is effective in treating infections caused by Gram-positive bacteria. These infections include hospital-acquired and community-acquired pneumonia, complicated and uncomplicated skin and soft tissue infections, and associated bacteremia (bloodstream infections). The availability of an IV, tablet and oral suspension formulation of Zyvox would allow physicians to select the appropriate administration route for their patients. Pharmacia & Upjohn submitted a New Drug Application (NDA) for Zyvox to the FDA in October 1999.
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