FDA approves new treatment for uncomplicated urinary tract infections in adult women who have limited or no alternative oral antibiotic treatment options

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-treatment-uncomplicated-urinary-tract-infections-adult-women-who-have-limited-or-no?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration has approved Orlynvah (sulopenem etzadroxil and probenecid) oral tablets for the treatment of uncomplicated urinary tract infection(s) (uUTI) caused by certain bacteria (Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis) in adult women who have limited or no alternative oral antibacterial treatment options. Orlynvah is not indicated for the primary or step-down treatment of complicated UTI (cUTI) or complicated intra-abdominal infections (cIAI). An uncomplicated UTI is a bacterial infection of the bladder in women with no structural abnormalities of their urinary tract. Approximately one-half of all women will experience at least one uUTI in their lifetime. The prescribing information includes warnings for hypersensitivity reactions, Clostridioides difficile-Associated Diarrhea (CDAD), and potential exacerbation of gout when given to patients with a known history of gout. Orlynvah is contraindicated in patients with a history of hypersensitivity reactions to the components of Orlynvah (sulopenem etzadroxil and probenecid) or other beta-lactam antibacterial drugs, patients with known blood dyscrasias, patients with known uric acid kidney stones, and patients who are also taking ketorolac tromethamine. The most common side effects of Orlynvah were diarrhea, nausea, vaginal yeast infection, headache, and vomiting. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213972s000lbl.pdf?utm_medium=email&utm_source=govdelivery