FDA Approves Sulopenem Etzadroxil and Probenecid for Uncomplicated UTIs
The FDA has approved just the second treatment for uncomplicated urinary tract infections (UTIs) in the last 2 decades.
The FDA has approved Iterum Therapeutics’ sulopenem etzadroxil and probenecid (Orlynvah) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneuomoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options, according to a company news release.1
Woman with urinary tract infection / 220 Selfmade studio / stock.adobe.com
The approval marks the first indication for the drug and just the second in uUTIs in 2 decades.
“Orlynvah offers new hope for patients suffering from difficult-to-treat uUTIs,” Corey Fishman, CEO of Iterum Therapeutics, said in the release.1 “The introduction of novel products, like Orlynvah, is an important way to combat microbial resistance to other approved oral agents and offers a potential solution to patients and physicians.”
The FDA approval of sulopenem etzadroxil and probenecid was supported by data from the phase 3 SURE 1 (NCT03354598) and REASSURE (NCT05584657) clinical trials.2,3,4 SURE 1 evaluated the safety and efficacy of sulopenem etzadroxil and probenecid compared with ciprofloxacin, and REASSURE compared the drug with amoxicillin and clavulanate (Augmentin), in the treatment of adult women with uUTI.
The SURE 1 trial was a randomized, noninferiority trial involving 1660 adult women with uUTIs. Sulopenem etzadroxil and probenecid demonstrated efficacy in patients infected with ciprofloxacin-resistant pathogens, achieving a composite response rate of 48% compared to 33% in the ciprofloxacin group.
The REASSURE trial was a randomized, noninferiority trial involving 2214 adult women with uUTIs. Sulopenem etzadroxil and probenecid demonstrated efficacy in patients infected with amoxicillin/clavulanate–susceptible pathogens, achieving a composite response rate of 62% compared with 55% in the amoxicillin/clavulanate group.
A total of 1932 patients were treated with sulopenem etzadroxil and probenecid across both trials.
“The FDA approval of Orlynvah is tremendous new for those of us who have been hoping for a new option to treat appropriate at-risk patients suffering from UTIs,” Marjorie Golden, MD, FIDSA, site chief, infectious disease at St. Raphael Campus Yale New Haven Hospital, said in a statement.1 “Based on the totality of clinical data generated, Orlynvah has the potential to be an important treatment alternative for use in the community.”
Per the FDA, sulopenem etzadroxil and probenecid is not indicated for primary or step-down treatment of complicated UTI or complicated intra-abdominal infections. It is taken as one oral tablet twice daily for 5 days.2
Up to 60% of women will develop a urinary tract infection during their lifetime, and up to 40% of women with a history of UTI will experience a recurrent infection. Approximately 40 million UTI prescriptions are dispensed annually in the United States, and it is estimated that approximately 1% of these infections are caused by antibiotic-resistant bacteria.1
According to Fishman,1 “As the first oral penem approved in the US, Orlynvah offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market.”
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References
1. Iterum therapeutics receives US FDA approval of Orlynvah (oral sulopenem) for the treatment of uncomplicated urinary tract infections. News release. Iterum Therapeutics. October 25, 2024. Accessed October 25, 2024. https://www.globenewswire.com/news-release/2024/10/25/2969543/0/en/Iterum-Therapeutics-Receives-U-S-FDA-Approval-of-ORLYNVAH-Oral-Sulopenem-for-the-Treatment-of-Uncomplicated-Urinary-Tract-Infections.html
2. FDA approves new treatment for uncomplicated urinary tract infections in adult women who have limited or no alternative oral antibiotic treatment options. News release. FDA. October 24, 2024. Accessed October 25, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-treatment-uncomplicated-urinary-tract-infections-adult-women-who-have-limited-or-no
3. Dunne MW, Aronin SI, Das AF, et al. Sulopenem or ciprofloxacin for the treatment of uncomplicated urinary tract infections in women: a phase 3, randomized trial. Clin Infect Dis. 2022;76(1):66–77. doi:10.1093/cid/ciac738
4. Iterum Therapeutics announces positive topline results from its phase 3 REASSURE clinical trial of oral sulopenem in uncomplicated urinary tract infections. News release. Iterum Therapeutics. January 30, 2024. Accessed October 25, 2024. https://www.iterumtx.com/news/press-releases/detail/116/iterum-therapeutics-announces-positive-topline-results-from
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