Redefining uUTI therapy: Orlynvah as a promising oral alternative (sulopenem etzadroxil and probenecid)

On December 24, the U.S. Food and Drug Administration approved Orlynvah (sulopenem etzadroxil, Iterum Therapeutics) as the first oral carbapenem for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. uUTIs, commonly caused by Escherichia coli, are limited to women without underlying comorbidities or anatomical abnormalities. Orlynvah, a prodrug hydrolyzed to sulopenem, exhibits broad-spectrum activity, including against multidrug-resistant and extended-spectrum β-lactamase-producing Enterobacteriaceae. The efficacy of Orlynvah was established through two large multicenter trials, which demonstrated superior outcomes compared to amoxicillin-clavulanate and improved efficacy over ciprofloxacin in cases involving resistant pathogens. The drug was generally well-tolerated, with few serious adverse events reported. Orlynvah offers a promising oral alternative in the era of rising antimicrobial resistance and represents a significant advancement in the management of uUTIs.