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Forest Laboratories Announces Positive Results from Phase III Clinical Studies of Ceftaroline for the Treatment of Complicated Skin and Skin Structure Infections
Date:6/19/2008

ally 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. The data were collected from 1396 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 a MRSA infection.

Ceftaroline was statistically proven non-inferior to 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 (TOC) visit in the clinically evaluable population across both studies. The studies were designed to a non-inferiority margin of 10% between ceftaroline and the comparator regimen. In addition, ceftaroline had a microbiological eradication rate of 92.4% compared to a vancomycin plus aztreonam rate of 93.6% for all pathogens when used as treatment for cSSSI. The ceftaroline clinical cure rate was 93.1% in Staphylococcus aureus infections in the microbiologically evaluable population and 93.3% for MRSA infections. The study also indicated that ceftaroline was generally well-tolerated. The overall rate of adverse events was comparable between the two treatment groups. The overall discontinuation rate for ceftaroline was 3.0% compared to 4.8% for vancomycin plus aztreonam.

About Complicated Skin and Skin Structure Infections (cSSSIs)

cSSSIs are caused by gram-positive bacteria, such as MRSA, and common gram-negative bacteria.(1,2) cSSSIs are among the most common infections treated in the hospital setting(3) and MRSA infections are becoming more common in patients in both the hospital and community settings, now the most frequent cause of cSSSI presenting to emergency departments in the United States (U.S.) and the cause of over 18,000 deaths in 2005.(4)

According to the Centers for Disease Control and P
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SOURCE Forest Laboratories, Inc.
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