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Pharmacia & Upjohn Zyvox

Executive Summary

Preliminary Phase III data presented at ICAAC indicate Zyvox (linezolid) is effective for the treatment of infections caused by Gram-positive bacteria in adults and children. An interim analysis determined 66.4% of patients treated with I.V. Zyvox plus aztreonam demonstrated clinical success in the treatment of hospital acquired pneumonia compared to 68.1% treated with I.V. vancomycin plus aztreonam. Equivalence was also demonstrated in a Phase III trial assessing the efficacy of Zyvox vs. oral cefpodoxime in the treatment of community acquired pneumonia (89.6% vs. 90.8%). Zyvox was more efficacious in treating CAP than I.V. ceftriaxone followed by cefpodoxime (93.3% vs. 69.9%). In the treatment of complicated skin and soft tissue infections, Zyvox was 90.7% effective vs. 86.3% for the comparator (I.V. oxacillin/oral dicloxacillin) treated group. Nausea (5.4%), diarrhea (5.2%), tongue discoloration (2.5%) and oral monilia (2.3%) were the most frequently reported adverse events in a Phase II safety and tolerance study. P&U anticipates an NDA filing by the end of 1999

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