Phase 3 results for Cubist antibiotic

The online edition of Lancet Infectious Diseases publishes the results of Cubist Pharmaceuticals' (CBST +1.9%) Phase 3 clinical trial of its investigational antibiotic Sivextro (tedizolid phosphate) for the treatment of acute bacterial skin and skin structure infections ((ABSSSI)) and complicated skin and soft tissue infections ((cSSTI)). The company is developing the once-daily oxazolidinone as an IV and oral therapy for the treatment of serious Gram-positive infections such as those caused by methicillin-resistant Staphylococcus aureus (MRSA).

Study results showed that a daily dose of 200 mg of Sivextro given IV over six days was non-inferior (no worse than) compared to a ten-day regimen of twice-daily IV 600 mg of linezolid for the treatment of ABSSSI.

The FDA's Anti-Infective Drugs Advisory Committee unanimously voted (14-0) in favor of approving Sivextro for ABSSSI infections on March 31, 2014.

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