Proven efficacy against ciprofloxacin-resistant pathogens1*
Composite response
Clinical cure
Microbiological response
In the ORLYNVAH clinical trial:
ORLYNVAH did not demonstrate efficacy in patients with ciprofloxacin-susceptible pathogens1
Clinical cure was similar across treatment groups in the patient population with ciprofloxacin-susceptible pathogens. However, there was a higher proportion of patients in the ORLYNVAH group with asymptomatic bacteriuria at the day 12 test-of-cure visit1,2
ORLYNVAH demonstrated superiority† against gram-negative uropathogens resistant to ciprofloxacin in uUTIs1,2
Study design1,2
Trial 2 (SURE-1; NCT03354598) was a Phase 3, randomized, multinational, double-blind, double-dummy, controlled, non-inferiority study to compare ORLYNVAH (500 mg by mouth twice daily for five days) to ciprofloxacin (250 mg by mouth twice daily for three days) for the treatment of uUTIs in adult female patients.
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 nonsusceptible (MIC ≥ 2 μg/mL) to ciprofloxacin.1,2
†Compared to ciprofloxacin group.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.1,2
CFU=colony forming unit; MIC=minimum inhibitory concentration; Micro-MITT=microbiological modified intent-to-treat; po bid=by mouth twice daily.
Consistent clinical response
Demonstrated clinical efficacy against amoxicillin/clavulanate in a Phase 3 clinical trial1,3
ORLYNVAH safety was evaluated in more than 1900 patients
The majority of adverse events were mild1-3