FDA Approves New Antibacterial Drug to Treat UTIs, Intra-Abdominal Infections

DECEMBER 20, 2014
Meghan Ross, Associate Editor
A new FDA-approved drug could help treat complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) among adults.

Cubist Pharmaceutical’s ceftolozane/tazobactam (Zerbaxa) is a new antibacterial drug product that uses a beta-lactamase inhibitor. Used in combination with metronidazole, Zerbaxa can help treat cIAI, according to the FDA.

In trials of Zerbaxa, a total of 979 patients were given either Zerbaxa plus metronidazole or meropenem, which is an FDA-approved antibacterial drug. According to the FDA, Zerbaxa and metronidazole was effective in treating cIAI.

Zerbaxa also proved effective in treating cUTI in a trial of 1068 adults who were given either Zerbaxa or levofloxacin, another antibacterial drug.

Common side effects related to Zerbaxa include nausea, diarrhea, headache, and fever. The drug also lists a warning about decreased efficacy among patients with renal impairment, according to the FDA.

Zerbaxa’s approval marks the fourth new antibacterial drug to be approved by the FDA this year, and it is also the fourth new antibacterial drug designated as a Qualified Infectious Disease Product (QIDP), which means the FDA considered it an antibacterial drug intended to treat a serious or life-threatening infection.

“The FDA approval of several new antibacterial drugs this year demonstrates the agency’s commitment to increasing the availability of treatment options for patients and physicians,” said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “We must continue to help foster the development of new antibacterial drugs and encourage prudent use of existing treatments to conserve their utility.”