Orlynvah Offers Hope Amid Rising Antibiotic Resistance In UTI Treatments
In October 2024, the U.S. Food and Drug Administration (FDA) approved Orlynvah™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women with limited or no alternative oral antibacterial options.
This approval marks the first oral penem antibiotic sanctioned in the U.S., offering a new solution for patients facing antibiotic-resistant infections.
Clinical Trials Demonstrate Efficacy Against Resistant Pathogens
Orlynvah’s approval was based on two Phase 3 clinical trials—SURE 1 and REASSURE. These studies evaluated its effectiveness against uUTI-causing bacteria, including strains resistant to commonly used antibiotics.
In SURE 1, Orlynvah showed superiority over ciprofloxacin in treating fluoroquinolone-resistant infections. REASSURE demonstrated non-inferiority to amoxicillin/clavulanate in susceptible populations.
Overall, Orlynvah was generally well-tolerated, highlighting its potential in addressing antibiotic-resistant uUTI strains.
Addressing The Growing Concern Of Antibiotic Resistance
Uncomplicated UTIs are among the most common bacterial infections, with approximately 40 million prescriptions issued annually in the U.S. However, rising antibiotic resistance has limited effective oral treatment options.
Orlynvah targets infections caused by Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, including strains producing extended-spectrum beta-lactamases (ESBLs) and those resistant to fluoroquinolones.
Its oral formulation allows for outpatient treatment, potentially reducing hospital stays and healthcare costs.
Safety Profile And Usage Guidelines
Orlynvah is administered as one oral tablet twice daily for five days. Common side effects include diarrhea, nausea, vaginal yeast infections, headache, and vomiting.
It is contraindicated in patients with known hypersensitivity to its components or other beta-lactam antibiotics, those with blood dyscrasias, uric acid kidney stones, or those concurrently taking ketorolac tromethamine.
Healthcare providers are advised to use Orlynvah judiciously to minimize the risk of developing further antibiotic resistance.
COrlynvah Ommercialization And Future Outlook
Iterum Therapeutics, the developer of Orlynvah, anticipates its commercial launch by mid-2025. The company is exploring strategic partnerships to maximize the drug’s reach and impact.
With its FDA approval, Orlynvah has received Fast Track designation, Qualified Infectious Disease Product (QIDP) status, and Priority Review, underscoring its significance in addressing unmet medical needs.
As the first branded uUTI product to enter the U.S. market in over 25 years, Orlynvah represents a significant advancement in the fight against antibiotic-resistant infections.
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