Ceftaroline trials prove effective against MRSA

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in Drug Development

Link: Forests Phase III skin infection study meets study end point – Pharmaceutical Business Review.

Forest Laboratories has announced positive results from two globally conducted, multi-center Phase III studies of ceftaroline, a broad-spectrum cephalosporin with activity against gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus and gram negative bacteria, for the treatment of complicated skin and skin structure infections.

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The two globally conducted, multi-center, Phase III, randomized, double-blind comparative studies were designed to evaluate the efficacy and safety of ceftaroline compared to vancomycin plus aztreonam.

In both the studies, ceftaroline as monotherapy achieved the primary endpoint of non-inferiority versus the combination of vancomycin plus aztreonam. Ceftaroline treated patients had a clinical cure rate of 91.6% compared to a vancomycin plus aztreonam clinical cure rate of 92.7% at test-of-cure visit in the clinically evaluable population across both studies.

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