Iterum Therapeutics has received FDA approval for its new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by designated microorganisms, marking a significant advancement in combating antimicrobial resistance. The approval is specifically for adult women who have limited or no alternative oral antibacterial treatment options.
Clinical Trial Data
The FDA's decision was supported by data from two pivotal Phase 3 clinical trials, SURE 1 and REASSURE. SURE 1 demonstrated the superiority of ORLYNVAH™ compared to ciprofloxacin in fluoroquinolone-resistant infections. REASSURE showed non-inferiority and statistical superiority to Augmentin™ in the Augmentin™-susceptible population. The drug was generally well-tolerated in both trials.
Addressing Unmet Needs in UTI Treatment
UTIs are common, with up to 60% of women experiencing a uUTI in their lifetime and up to 40% experiencing a recurrence. Approximately 40 million uUTI prescriptions are generated annually in the United States. Rising antibiotic resistance and suboptimal safety profiles of existing oral treatments have made antibiotic selection increasingly challenging.
Mechanism of Action and Spectrum
ORLYNVAH™ is a novel oral penem antibiotic with potent activity against Enterobacterales species, including those that encode extended-spectrum beta-lactamases (ESBL) or AmpC-type beta-lactamases, which confer resistance to third-generation cephalosporins.
Safety Information
ORLYNVAH™ is contraindicated in patients with hypersensitivity to beta-lactam antibacterial drugs, known blood dyscrasias, uric acid kidney stones, or concomitant use of ketorolac tromethamine. Common adverse reactions include diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting.
Company Strategy
Corey Fishman, Iterum’s Chief Executive Officer, stated that the company will renew its efforts to achieve a strategic transaction involving ORLYNVAH™ to maximize value for its stakeholders, now with FDA approval and a clear label.
