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AstraZeneca announces top-line results from Phase III studies of antibiotic CAZ-AVI

The investigational antibiotic CAZ-AVI was studied in patients with intra-abdominal infections (cIAI).

 
PRLog - Aug. 19, 2014 - WASHINGTON, D.C. -- AstraZeneca announced successful results from a Phase III study investigating the antibiotic ceftazidime-avibactam (CAZ-AVI) as a treatment for hospitalized adult patients with complex intra-abdominal infections.

CAZ-AVI is an investigational antibiotic consisting of cephalosporin (ceftazidime), conventionally used to treat serious bacterial infections and non-beta lactam beta-lactamase inhibitor (avibactam). CAZ- AVI’s importance stems from its ability to treat various Gram-negative bacterial infections which pose a serious threat to public health as certain strains have become resistant to antibiotics.  CAZ-AVI’s effectiveness is a result of avibactam protecting ceftazidime from being broken down by beta-lactamases that are produced by resistant bacteria.

The Phase III studies, RECLAIM-1 and RECLAIM-2 evaluated the safety and efficacy of CAZ-AVI in  hospitalized adult patients with complicated intra-abdominal infections. CAZ-AVI, administered intravenously as a two hour infusion (2000 mg / 500 mg) plus metronidazole, compared to meropenem, administered intravenously as a 30 minute infusion (1 g). The data revealed CAZ-AVI produced higher statistical significance compared meropenem. According to the company, ‘The primary endpoint was a clinical cure rate 28 to 35 days after randomization (the Test of Cure visit)’

“We are very encouraged by these results which highlight the potential for CAZ-AVI to provide a much-needed new treatment option for serious and life-threatening intra-abdominal infections, especially where antibiotic resistance poses a threat to treatment,” said Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca.

CAZ-AVI is also currently being studied to treat complicated urinary tract infections (cUTI), nosocomial pneumonia and for the treatment of cIAI and cUTI patients with ceftazidime-resistant infections

CAZ-AVI is a joint collaboration with Forest Laboratories, a wholly-owned subsidiary of Actavis. AstraZeneca holds the global rights to commercialize CAZ-AVI, however , Forest Laboratories will assume the rights to market in North America

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