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Orlynvah is approved for uncomplicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.
Updated October 25, 2024, at 2:41 pm.
The FDA approved sulopenem etzadroxil and probenecid (Orlynvah; Iterum Therapeutics) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial option.1
Image Credit: Vitalii Vodolazskyi - stock.adobe.com
“Orlynvah offers new hope for patients suffering from difficult-to-treat uUTIs. The introduction of novel products, like Orlynvah, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians,” Corey Fishman, CEO of Iterum, said in a news release. “As the first oral penem approved in the US, Orlynvah offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market.”1
The approval was based on the SURE 1 and REASSURE trials, which evaluated the safety and efficacy of the drug compared with ciprofloxacin and with amoxicillin and clavulanic acid (Augmentin; GSK), respectively.1
In the SURE 1 (NCT03354598) trial, investigators used a randomized, multicenter, double-blinded design that compared the oral drug with oral ciprofloxacin, according to the study authors. The study was conducted from August 2018 through January 2020 at 142 centers in 4 counties. Patients received randomized treatment in a 1:1 ratio, with those receiving sulopenem etzadroxil and probenecid taking the table twice daily for 5 days and those receiving ciprofloxacin taking it twice daily for 3 days. The primary end point was overall response, and additional endpoints included clinical response on day 12, overall and clinical responses at the end of treatment and the final visit on day 28, and adverse events.2
Trial Name: Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women
ClinicalTrials.gov ID: NCT03354598
Sponsor: Iterum Therapeutics International Limited
Completion Date: January 2020
The results showed that sulopenem etzadroxil and probenecid was superior at 62.6% compared with ciprofloxacin at 36%. Additionally, in susceptible populations, investigators found that the drug was not noninferior at 66.8% and 78.6%, respectively. Diarrhea was reported more frequently with the study drug at 12.4% compared with ciprofloxacin at 2.5%.2
In the REASSURE study, the drug showed non-inferiority to amoxicillin and clavulanic acid, showing an overall response of 61.7% compared with 55%, respectively. Clinical success and microbiological success were 77.3% with 75.2% sulopenem etzadroxil and probenecid, respectively, and 76.7% and 66.7% with amoxicillin and clavulanic acid, respectively.3
The REASSURE study was a randomized, multicenter, double-blinded trial with 2222 individuals, according to a news release. Patients received either the study drug twice daily for 5 days or amoxicillin and clavulanic acid twice daily for 5 days.3
“The FDA approval of Orlynvah is tremendous news 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 of infectious disease at St. Raphael Campus Yale New Haven Hospital, said in the news release. “Based on the totality of clinical data generated, Orlynvah has the potential to be an important treatment alternative for use in the community.”1
