Posted by Michael Wonder on 12 Jul 2022
Iterum Therapeutics announces special protocol assessment agreement with the FDA
11 July 2022 - SPA supports protocol for Phase 3 clinical trial of oral sulopenem for the treatment of uncomplicated urinary tract infections.
Iterum Therapeutics announced today that it has reached an agreement with the U.S. FDA under the special protocol assessment process on the design, outcomes and statistical analysis of a Phase 3 clinical trial for oral sulopenem etzadroxil with probenecid for the treatment of uncomplicated urinary tract infections.
The agreement provides that the design and planned analysis of the trial, as set out in the protocol submitted to the FDA, adequately addresses the objectives necessary to support the potential resubmission of the Company’s new drug application for oral sulopenem etzadroxil with probenecid.
