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A phase II open-label, clinical study of Zyvox, under development by Pharmacia & Upjohn, shows the compound is active against gram- positive bacteria, including those resistant to other antibiotics. Zyvox comes from the oxazolidinone class of antibiotics, the first new class in more than 30 years.
Zyvox works by attacking bacteria before the bacterial growth cycle, a new approach much different from any other antibiotic. Zyvox has both intravenous and oral formulations and has shown in vitro activity against bacteria resistant to other antibiotics.
The Phase II study evaluated 273 patients. S. aureus was the most common organism isolated, with other isolates including S. epidermidis, S. pyogenes, and enterococcus.
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) Zyvox IV for a minimum of three days, then switched to oral Zyvox until the end of therapy. Follow-up evaluations occurred at one to 14 days and again at 15 to 28 days after end of therapy.
A clinical success rate of 94.8% was shown in patients with suspected community-acquired S. pneumoniae. The most common drug-related medical events reported in the studies were headache, nausea, and diarrhea.
Zyvox is now in Phase III clinical trials and is being studied for the treatment of skin and soft tissue infections, pneumonia, and bacteremia caused by gram-positive bacteria such as methicillin-resistant S. aureus and vancomycin-resistant enterococci.