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In late 2024, the U.S. FDA approved an oral “penem” antibiotic, sulopenem etzadroxil (Orlynvah), for treating patients with uncomplicated urinary tract infections (UTIs); its potential advantage is activity against resistant Enterobacterales organisms (NEJM JW Infect Dis Nov 20 2024; [e-pub]). The drug is marketed in combination with probenecid to delay its excretion. The principal manufacturer-sponsored randomized trial that led to FDA approval now has been published.
About 2200 adult women with symptoms of uncomplicated UTI — and urine positive for nitrites, leukocyte esterase, or isolated pyuria — received 5-day courses of sulopenem etzadroxil or amoxicillin/clavulanate. The primary efficacy analysis was limited to the ≈1000 patients whos…