Merck & Co., Inc. (NYSE:MRK) Reports Pivotal Data from Phase 3 Clinical Studies of ZERBAXA Print E-mail
By Marilyn Mullen   
Wednesday, 29 April 2015 16:54

Merck & Co., Inc.(NYSE:MRK) has confirmed that The Lancet and Clinical Infectious Diseases published online results from pivotal Phase 3 clinical studies of ZERBAXA for Injection in complicated urinary tract infections as well as complicated intra-abdominal infections.


The results would also be there in the upcoming print issues of journals. The firm had acquired ZERBAXA as part of the purchase of Cubist Pharmaceuticals, Inc.

The publications give details on results of two big Phase 3 clinical studies of ZERBAXA.

Both studies qualified for pre-specified primary endpoints and secondary analyses results demonstrate consistency with primary outcomes.

René Russo, Pharm.D, BCPS, vice president, global medical affairs, Cubist Pharmaceuticals, opined that physicians require new treatment options for addressing complex infections which happen due to serious Gram-negative bacteria.

He added that the publication gives more information on the infectious disease community besides supporting ZERBAXA as new treatment for some complicated urinary tract and intra-abdominal infections.

ZERBAXA may be used along with metronidazole in adult patients for treating complicated intra-abdominal infections resulting from Gram-negative and Gram-positive microorganisms such as Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Pseudomonas aeruginosa, Proteus mirabilis , Bacteroides fragilis, Streptococcus constellatus, Streptococcus anginosus and Streptococcus salivarius.

Tthe drug may also be used for treating complex urinary tract infections such as pyelonephritis that happen because of Gram-negative microorganisms like Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae and Pseudomonas aeruginosa.

Zerbaxa should only be used for treating infections resulting out of susceptible bacteria. When culture and susceptibility information are there, they should be taken into account for altering or selecting antibacterial therapy.

If the data is not available, then local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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