NEW YORK -- September 2, 2008 -- Health Canada has approved ceftobiprole medocaril IV (Zeftera) for the treatment of complicated skin and skin structure infections (cSSSI), including non-limb-threatening diabetic foot infections without concomitant osteomyelitis.
Ceftobiprole medocaril IV is also effective against methicillin-resistant Staphylococcus aureus (MRSA).
The approval was based on results of 2 phase 3, double-blind, randomised, multicentre, global trials involving 817 patients with cSSSI.
The first study demonstrated the efficacy of ceftobiprole medocaril compared with vancomycin alone in patients with suspected or confirmed gram-positive cSSSI, and a second study demonstrated the effectiveness of ceftobiprole medocaril when compared with vancomycin plus ceftazidime.
The second phase 3 trial included patients with non-limb-threatening diabetic foot infections. Pathogens identified at baseline in this subpopulation included methicillin-sensitive S. aureus (38%), MRSA (13%), Enterobacter cloacae (9%), and Proteus mirabilis (7%). The results demonstrated the effectiveness of ceftobiprole medocaril when compared with vancomycin plus ceftazidime.
In both studies, ceftobiprole medocaril was well tolerated. The most common treatment-emergent adverse reactions were nausea (9%), taste disturbance (6%), diarrhoea (5%), and vomiting (5%).
SOURCE: Environics Communications Press Release
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