Action

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).

Orlynvah is taken as one oral tablet twice daily for 5 days. 

Disease or Condition 

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. 

Effectiveness 

The effectiveness of Orlynvah was evaluated in two phase 3 controlled, randomized, double blind clinical trials (Trial 1 and Trial 2) which enrolled adult women with uUTI. Orlynvah was administered as one tablet twice daily for 5 days. 

Trial 1 (NCT05584657) was a noninferiority trial in which 2214 adult women with uUTI were randomized and treated. Orlynvah demonstrated efficacy in patients with amoxicillin/clavulanate-susceptible pathogens with a composite response rate (combined microbiological response and clinical response) of 62% compared to a composite response rate of 55% in the amoxicillin/clavulanate group. Trial 2 (NCT03354598) was a noninferiority trial in which 1660 adult women with uUTI were randomized and treated. Orlynvah demonstrated efficacy in patients with ciprofloxacin-resistant pathogens with a composite response rate of 48% compared to a composite response rate of 33% in the ciprofloxacin group. Overall, in the two trials combined, 1932 patients were treated with Orlynvah.

Clinical trials evaluating Orlynvah for the treatment of patients with cUTI and cIAI did not demonstrate effectiveness.

Safety Information

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. 

See the full prescribing information for additional information on risks associated with Orlynvah. 

Designations

This application received Fast Track designation, Qualified Infectious Disease Product (QIDP) designation and Priority Review.