US Food and Drug Administration (FDA) approved a new oral antibiotic to treat uncomplicated urinary tract infections (UTIs).

Orlynvah (sulopenem etzadroxil and probenecid) is a broad-spectrum oral penemic antibiotic designed to treat urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis bacteria in adult women who have limited or no alternative treatment options. Iterum Therapeutics created the drug.

The FDA said it approved the drug based in part on two phase 3 randomized controlled trials that compared Orlynvah with standard treatments for uUTIs.

A study of 2,214 adult women who had a UTI found that women treated with Orlynvah had a combined response rate of 62% (microbiological and clinical response combined), compared with a composite response rate of 55% in patients treated with amoxicillin/clavulanate. In another study of 1,660 adult women with UTIs caused by ciprofloxacin-resistant pathogens, Orlynvah was superior to ciprofloxacin, with a composite response rate of 48% compared with 33% in the ciprofloxacin group.

The most common side effects women experienced with Orlynvah were diarrhea, nausea, vaginal yeast infection, headache, and vomiting.

“Orlynvah offers new hope to patients suffering from difficult-to-treat UTIs,” Corey Fishman, interim CEO of Iterum Therapeutics, said in a company statement. press 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.”

At the FDA’s Antimicrobial Drug Advisory Committee on Sept. 10, committee members agreed that Orlynvah could be beneficial for some patients, but were concerned that off-label use could increase resistance to carbapenems, which are closely related to penems and an important class of antibiotics. for serious, multidrug-resistant infections.

“While an oral penem for the treatment of resistant bacteria causing UTIs may address an unmet need, its use in an outpatient setting where treatment is most often empiric raises concerns that inappropriate use may contribute to AMR (antimicrobial resistance )”, the agency said in a document.

Careful antimicrobial stewardship is “necessary to ensure appropriate placement of sulopenem etzadroxil/probenecid in the hierarchy of treatment options for uUTI.” Orlynvah is the first oral penem approved in the US. FDAs prescribing information states that Orlynvah should only be used to treat uUTIs that are or are believed to be caused by susceptible bacteria. The drug has not been approved as primary or step-down treatment for complicated UTIs or for complicated intra-abdominal infections.