Iterum Therapeutics (Nasdaq: ITRM) has achieved FDA approval for ORLYNVAH™ (sulopenem etzadroxil and probenecid), marking the first oral penem antibiotic approved in the United States for the treatment of uncomplicated urinary tract infections (uUTIs). This approval provides a new treatment option for adult women who have limited or no alternative oral antibacterial treatments available for designated microorganisms.
The FDA's decision was supported by data from two Phase 3 clinical trials, SURE 1 and REASSURE. The SURE 1 trial demonstrated the superiority of ORLYNVAH™ over ciprofloxacin in treating fluoroquinolone-resistant infections. The REASSURE trial showed non-inferiority and statistical superiority of ORLYNVAH™ compared to Augmentin™ in susceptible populations. These findings highlight the potential of ORLYNVAH™ as a valuable treatment alternative, particularly in the face of rising antibiotic resistance.
Clinical Trial Data
The SURE 1 trial compared ORLYNVAH™ to ciprofloxacin in adult women with uUTIs. Results indicated that ORLYNVAH™ was superior in patients with fluoroquinolone-resistant infections. The REASSURE trial compared ORLYNVAH™ to Augmentin™ in a similar patient population, demonstrating non-inferiority and statistical superiority in the Augmentin™-susceptible group. These trials collectively support the efficacy and safety profile of ORLYNVAH™.
Addressing Unmet Needs in uUTI Treatment
Urinary tract infections are among the most common bacterial infections, with up to 60% of women experiencing a uUTI in their lifetime. Recurrence rates are also high, with up to 40% of women with a history of uUTIs experiencing a subsequent infection. The rise of antibiotic resistance has complicated treatment strategies, making the approval of new agents like ORLYNVAH™ crucial.
Corey Fishman, Iterum’s Chief Executive Officer, stated, "ORLYNVAH™ offers new hope for patients suffering from difficult-to-treat uUTIs...[and] offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market."
Safety and Tolerability
In both the SURE 1 and REASSURE clinical trials, ORLYNVAH™ was generally well-tolerated. Common adverse reactions included diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting. The prescribing information includes warnings and precautions regarding hypersensitivity reactions and Clostridioides difficile-associated diarrhea.
Strategic Implications for Iterum Therapeutics
With FDA approval secured, Iterum Therapeutics is now focusing on strategic transactions to maximize value for its stakeholders. This may involve partnering, licensing, or selling rights to ORLYNVAH™. The company believes that the unique positioning of ORLYNVAH™ as the first oral penem in the U.S. creates substantial market opportunities, especially given the growing concerns about antimicrobial resistance.
Marjorie Golden, MD, FIDSA, Site Chief, Infectious Disease, St. Raphael Campus Yale New Haven Hospital, commented, "Based on the totality of clinical data generated, ORLYNVAH™ has the potential to be an important treatment alternative for use in the community."
