FDA Approves Iterum's Oral Sulopenem (ORLYNVAH™) for Uncomplicated Urinary Tract Infections
Key Insights
The FDA has approved ORLYNVAH™ (search) (oral sulopenem) by Iterum Therapeutics (search) for treating uncomplicated urinary tract infections (search) (uUTIs) in adult women.
ORLYNVAH™ (search) is the first oral penem antibiotic approved in the U.S., offering a new treatment option for uUTIs caused by specific microorganisms.
Approval was based on Phase 3 trials (SURE 1 and REASSURE) demonstrating efficacy and tolerability compared to ciprofloxacin and Augmentin™ (search).
Iterum Therapeutics (search) announced that the U.S. Food and Drug Administration (FDA) has approved ORLYNVAH™ (search) (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (search) (uUTIs) in adult women with limited oral antibacterial treatment options. This marks the first FDA-approved product for Iterum and a significant advancement in combating antimicrobial resistance.
The approval of ORLYNVAH™ (search) is based on data from two pivotal Phase 3 clinical trials, SURE 1 and REASSURE. SURE 1 demonstrated superiority to ciprofloxacin in fluoroquinolone-resistant infections, while REASSURE showed non-inferiority and statistical superiority to Augmentin™ (search) in Augmentin™-susceptible populations. The drug was generally well-tolerated in both trials.
Clinical Trial Data
The SURE 1 trial compared ORLYNVAH™ (search) to ciprofloxacin in adult women with uUTIs. Results indicated that ORLYNVAH™ was superior in treating infections resistant to fluoroquinolones. The REASSURE trial compared ORLYNVAH™ to Augmentin™ (search), demonstrating non-inferiority and statistical superiority in the Augmentin™-susceptible population. These findings support ORLYNVAH™ as a valuable option for patients with limited treatment alternatives.
Addressing Unmet Needs in uUTI Treatment
Uncomplicated UTIs are common, with up to 60% of women experiencing one in their lifetime and up to 40% experiencing a recurrence. With approximately 40 million uUTI prescriptions generated annually in the United States, rising antibiotic resistance is making treatment more challenging. ORLYNVAH™ (search) offers a potential solution, particularly for infections resistant to commonly available oral antibiotics.
Safety and Efficacy
ORLYNVAH™ (search) is indicated for uUTIs caused by Escherichia coli (search), Klebsiella pneumoniae (search), or Proteus mirabilis (search) in adult women with limited or no alternative oral antibacterial treatment options. Common adverse reactions reported in clinical trials included diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting. The drug is contraindicated in patients with hypersensitivity to beta-lactam antibacterial drugs, known blood dyscrasias, uric acid kidney stones, and concomitant use of ketorolac tromethamine.
Company Strategy
Corey Fishman, Iterum’s Chief Executive Officer, stated that ORLYNVAH™ (search) offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market. Iterum plans to pursue a strategic transaction involving ORLYNVAH™ to maximize value for stakeholders.