FDA approves oral sulopenem ezadroxil and probenecid (Aurimba) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by certain bacteria in women with limited or no alternatives to oral antimicrobial treatment did. the agency said Friday.
This drug is a combination of a penem antibiotic (sulopenem ezadroxil) and a renal tubular transport inhibitor (probenecid). Treatment of uUTIs caused by: Escherichia coli, Klebsiella pneumoniaeor Proteus mirabilis It is the first oral penem approved for use in the United States. Itelm Therapeutics said:.
The FDA emphasized that this therapy is not indicated for the primary or step-line treatment of complicated urinary tract infections or complicated intra-abdominal infections.
The agency’s decision was supported by two Phase III non-inferiority studies: SURE-1A paper comparing the safety and efficacy of sulopenem ezadroxil/probenecid and ciprofloxacin, and rest assuredcompared with amoxicillin/clavulanic acid.
in SURE-1 In a study of sulopenem ezadroxil/probenecid in 1,660 women with uUTI, the combined response rate (combined microbiological and clinical response) was 48% in the ciprofloxacin group compared to 48% in the ciprofloxacin group. In the profloxacin group, the rate was 33%. in rest assured In a study of 2,214 women, the combined response rate for sulopenem ezadroxil/probenecid was 62% compared to 55% for the amoxicillin/clavulanate group.
The FDA said clinical trials evaluating antibiotics for complicated urinary tract infections and complicated intra-abdominal infections did not show efficacy.
Sulopenem Ezadroxil/Probenecid is taken as 1 tablet twice daily for 5 days. The most common side effects in patients treated with this drug were diarrhea, nausea, vulvovaginal fungal infections, headache, and vomiting.
Prescription information Contains a warning for hypersensitivity reactions. clostridioides difficile– Associated diarrhea, and possible exacerbation of gout. This treatment is contraindicated in patients with a history of hypersensitivity to the drug’s components or other beta-lactam antibiotics, in patients with known blood disorders or uric acid kidney stones, or in patients taking ketorolac/tromethamine. It is.
In 2021, the FDA rejected the oral antibiotic based on mixed data from another Phase III trial and recommended that Iterum conduct additional testing. After completing REASSURE, the company resubmitted the new drug application in 2024.
Prior to last month’s Antibiotics Advisory Committee meeting, FDA reviewers expressed continued concerns about the benefits and risks of oral treatments, including the potential for inappropriate use. FDA advisers echoed these concerns.
