FDA Approves New Treatment for Uncomplicated UTIs: Daily Dose

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On October 25, 2024, we reported on the US Food and Drug Administration (FDA) approval of a new drug application for oral sulopenem (sulopenem etzadroxil and probenecid, Iterum Therapeutics) for the treatment of uncomplicated urinary tract infections (uUTIs).

The approval

Oral sulopenem (Orlynvah) is indicated for the treatment of uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. It is the first oral penem approved in the US.

The FDA approval was based on results from the pivotal SURE 1 and REASSURE phase 3 clinical trials. The SURE 1 trial evaluated the safety and efficacy of oral sulopenem compared to ciprofloxacin, and the REASSURE trial compared it with oral amoxicillin/clavulanate.

Results from the SURE 1 study showed superiority to ciprofloxacin in fluoroquinolone resistant infections and noninferiority to ciprofloxacin in the treatment of patients with a quinolone-susceptible uropathogen. Data from REASSURE showed noninferiority and statistical superiority to amoxicillin/clavulanate in regard to the trial’s primary end point of overall response rate (combined clinical cure plus microbiologic eradication) in the treatment of people with uUTI. Oral sulopenem was generally well tolerated in both trials.

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