Merck Announces Publication of Pivotal Data from Phase 3 Clinical Studies of ZERBAXA

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The FINANCIAL — Merck, known as MSD outside the United States and Canada, on April 27 announced that The Lancet and Clinical Infectious Diseases have published online the results from the 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), respectively.

The results will also appear in forthcoming print issues of the journals. Merck acquired ZERBAXA as a part of its purchase of Cubist Pharmaceuticals, Inc., according to Merck.

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.

“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.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.


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