Merck Announces Publication of Pivotal Data from Phase III Clinical Studies of Zerbaxa

Merck (MSD outside the US and Canada) has announced that The Lancet and Clinical Infectious Diseases have published online the results from the pivotal Phase III 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.

The publications report the results of two large, global, Phase III 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 III 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, vice president, global medical affairs, Cubist Pharmaceuticals.