Proven response in the amoxicillin/clavulanate-susceptible group1*
Composite response
Clinical cure
Microbiological response
In the ORLYNVAH clinical trial1:
ORLYNVAH demonstrated efficacy against gram-negative uropathogens susceptible to amoxicillin/clavulanate in uUTIs
The amoxicillin/clavulanate-resistant population was small (n=67) and had insufficient power to draw conclusions regarding efficacy
Study design1,2
Trial 1 (REASSURE; NCT05584657) was a Phase 3, multicenter, randomized, double-blind, double-dummy, non-inferiority trial comparing ORLYNVAH (sulopenem etzadroxil 500 mg/probenecid 500 mg by mouth twice daily for 5 days) to amoxicillin/clavulanate (875 mg/125 mg by mouth twice daily for 5 days) in adult women with uUTIs.
Primary endpoint1,2:
Composite response (clinical cure and microbiologic response) at Day 12 in the micro-MITT† population
Clinical cure: resolution of uUTI symptoms and no new symptoms
Microbiological response: eradication of the baseline pathogen to < 103 CFU/mL in the urine
Micro-MITT population with baseline pathogens susceptible (MIC ≤ 8/4 μg/mL) to amoxicillin/clavulanate.1
†Micro-MITT population included all patients who had at least 1 uropathogen isolated at baseline (≥ 105 CFU/mL) regardless of susceptibility to amoxicillin/clavulanate and received at least 1 dose of the study drug.1
CFU=colony-forming unit; MIC=minimum inhibitory concentration; Micro-MITT=microbiological modified intent-to-treat; po bid=by mouth twice daily.
Demonstrated clinical response
Proven efficacy against ciprofloxacin-resistant pathogens1,3
ORLYNVAH safety was evaluated in more than 1900 patients
The majority of adverse events were mild1-3