Avycaz, Doripenem for cUTI Compared in Phase 3 Studies
Allergan announced positive topline results from RECAPTURE 1 and 2, the pivotal Phase 3 studies evaluating the antibiotic Avycaz (ceftazidime-avibactam) as a treatment for adult hospitalized patients with complicated urinary tract infections (cUTI), including pyelonephritis.
RECAPTURE 1 and RECAPTURE 2 are Phase 3, randomized, multi-center, double-blind, double-dummy, parallel-group, comparative studies to determine the efficacy, safety, and tolerability of Avycaz vs. doripenem in the treatment of cUTI in hospitalized adults. The co-primary endpoints were: (1) symptomatic resolution of UTI-specific symptoms except flank pain and resolution of, or improvement in, flank pain based on the patient-reported symptom assessment response at the Day 5 visit, and (2) proportion of patients with both a symptomatic resolution of UTI-specific symptoms at Test of Cure (TOC) visit and a favorable microbiological response at TOC. The co-primary analysis was conducted in the Microbiological Modified Intent-to-Treat (mMITT) population and the non-inferiority margin was 10%.
In both studies, Avycaz met the objective of statistical non-inferiority compared to doripenem for both co-primary endpoints. The lower and upper bounds of the 95% confidence interval for the difference (CAZ-AVI – doripenem) in the percentage of patients for (1) were -2.39% and 10.42% respectively and for (2) were 0.30% and 13.12% respectively.
Avycaz consists of a cephalosporin, ceftazidime, and the first and only non-beta lactam beta-lactamase inhibitor, avibactam. The addition of avibactam protects ceftazidime from being broken down by certain beta-lactamases that are produced by resistant bacteria. Allergan plans to submit this data as a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) by the end of 2015.
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