Iterum Therapeutics plc (ITRM) has received U.S. FDA approval for ORLYNVAH™ (sulopenem etzadroxil and probenecid), an oral treatment for uncomplicated urinary tract infections (uUTIs) in adult women with limited treatment options.
This approval makes ORLYNVAH™ the first oral penem antibiotic in the U.S., meeting the need for treating resistant bacteria.
ORLYNVAH™: Addressing Critical Need in uUTI Treatment
Urinary tract infections are among the most common bacterial infections, affecting 60% of women in their lifetime.
Approximately 40 million UTI prescriptions are issued annually in the U.S., with rising antibiotic resistance creating challenges in effective treatment.
ORLYNVAH™ offers a targeted treatment for infections from Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, especially for limited-option patients.
Corey Fishman, CEO of Iterum Therapeutics, noted,
ORLYNVAH™ offers new hope for patients with challenging uUTIs. As the first oral penem antibiotic in the U.S., it provides a critical alternative for managing resistant infections.”
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Clinical Trials Confirm ORLYNVAH™’s Efficacy and Safety
FDA approval was based on two pivotal Phase 3 studies—SURE 1 and REASSURE—that demonstrated ORLYNVAH™’s efficacy and safety.
In SURE 1, ORLYNVAH™ outperformed ciprofloxacin for fluoroquinolone-resistant infections, while REASSURE showed it was superior to Augmentin™ in susceptible patients. Both studies confirmed ORLYNVAH™’s tolerability and effectiveness, making it a valuable option for resistant infections.
Dr. Marjorie Golden, an infectious disease expert at Yale New Haven Hospital, praised the drug, saying,
ORLYNVAH™ is a breakthrough for treating UTIs in at-risk patients. The clinical data supports its potential as an essential alternative in community care.”
Dr. Marjorie Golden
Strategic Vision and Market Potential for ORLYNVAH™
With FDA approval, Iterum Therapeutics is exploring strategic options to maximize the oral treatment’s market value, including partnerships or commercial transactions.
The company aims to address the needs of underserved uUTI patients amid rising resistance rates and limitations in current oral antibiotics.
ORLYNVAH™ has significant market potential, especially as it combats resistant infections with potency against Enterobacterales species, including those with ESBL or AmpC-type beta-lactamase resistance.
Combatting Antibiotic Resistance with ORLYNVAH™
With antimicrobial resistance on the rise, this oral treatment provides an essential new tool for effectively targeting resistant pathogens.
Its unique oral penem formulation offers patients a convenient and effective treatment option, supporting better outcomes and promoting responsible antibiotic use, a crucial factor in public health today.
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