Results from pivotal Phase 3 clinical studies of Zerbaxa™ (ceftolozane/tazobactam) for injection (1 g/0.5 g) in complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) have been published.
Merck acquired Zerbaxa as a part of its purchase of Cubist Pharmaceuticals, Inc.
The publications report the results of two large, global, Phase 3 clinical studies of Zerbaxa – a study in patients with cUTI and a study in patients with cIAI. Both studies met the pre-specified primary endpoints, and results of the secondary analyses for the studies were consistent with and supportive of the primary outcomes.
Zerbaxa Phase 3 results supports its use as a treatment for complicated urinary tract infections
“Physicians are in need of new treatment options to address complicated infections caused by serious Gram-negative bacteria. Publication of the Zerbaxa Phase 3 clinical study results in The Lancet and Clinical Infectious Diseases provides additional information to the infectious disease community and continues to support Zerbaxa as a new treatment for certain complicated urinary tract and complicated intra-abdominal infections,” said René Russo, Pharm.D, BCPS, vice president, global medical affairs, Cubist Pharmaceuticals.
Approved in the U.S., Zerbaxa is indicated for use in combination with metronidazole in adult patients for the treatment of complicated intra-abdominal infections caused by the following Gram-negative and Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus and Streptococcus salivarius. Zerbaxa also is indicated in adult patients for the treatment of complicated urinary tract infections, including pyelonephritis, caused by the following Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Pseudomonas aeruginosa.
