Positive Ph III data for Forest's MRSA drug

USA-based pharmaceutical company Forest Laboratories has announced positive Phase III results for ceftaroline, a broad-spectrum cephalosporin for the treatment of complicated skin and skin-structure infections, such as methicillin-resistant Staphylococcus aureus.

The global, multicenter, Phase III, randomized, double-blind comparative studies, CANVAS I and CANVAS II, were designed to evaluate the efficacy and safety of ceftaroline compared to vancomycin plus aztreonam. The data were collected from 1,396 adult patients (702 CANVAS I and 694 CANVAS II), with cSSSI caused by gram-positive and gram-negative bacteria. Over 30% of patients with a confirmed pathogen had the MRSA infection. In both the studies, ceftaroline achieved the primary endpoint of non-inferiority and the drug was generally well tolerated, according to the firm. Detailed results are expected to be presented later this year at a medical conference.

Ceftaroline is a novel, bactericidal injectable broad-spectrum cephalosporin being developed as a therapeutic agent to treat both common gram-negative organisms and gram-positive pathogens, including MRSA and multi-drug resistant Streptococcus pneumoniae. The drug has also shown bactericidal activity against vancomycin-resistant Staphylococcus aureus, linezolid-resistant S. aureus as well as penicillin-resistant Streptococcus pneumoniae. Ceftaroline is also being studied in Phase III clinical studies to indicate it for treatment of community-acquired pneumonia.