FDA

FDA greenlights novel treatment for uncomplicated UTI

October 28, 2024

Brand name: Orlynvah

Generic name: sulopenem etzadroxil and probenecid

Manufacturer: Iterum Therapeutics

Approval date: October 25, 2024

Orlynvah (sulopenem etzadroxil and probenecid) oral tablets are indicated for the treatment of uncomplicated urinary tract infection (uUTI) caused by certain bacteria (E. coli, K. pneumoniae, or P. mirabilis) in adult women who have limited or no alternative oral antibacterial treatment options.

Note: Orlynvah is not indicated for the primary or step-down treatment of complicated UTI (cUTI) or complicated intra-abdominal infections (cIAI).

Effectiveness

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

Trial 1 (NCT05584657) was a noninferiority trial in which 2,214 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% vs. 55% in the amoxicillin/clavulanate group.

Trial 2 (NCT03354598) was a noninferiority trial in which 1,660 adult women with uUTI were randomized and treated. Orlynvah demonstrated efficacy in patients with ciprofloxacin-resistant pathogens with a composite response rate of 48% vs. 33% in the ciprofloxacin group.

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

Safety

The prescribing information includes warnings for hypersensitivity reactions, C. difficile-associated diarrhea (CDAD) and potential exacerbation of gout when given to patients with a known history of gout.

Contraindications

• hypersensitivity reactions to the components of Orlynvah (sulopenem etzadroxil and probenecid) or other beta-lactam antibacterial drugs
• known blood dyscrasias
• known uric acid kidney stones
• patients who are also taking ketorolac tromethamine

The most common side effects of Orlynvah in clinical trials were:

• diarrhea
• nausea
• vaginal yeast infection
• headache
• vomiting

Recommended dose

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

Source:

FDA. (2024, October 24). FDA approves new treatment for uncomplicated urinary tract infections in adult women who have limited or no alternative oral antibiotic treatment options. [Press release]. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-treatment-uncomplicated-urinary-tract-infections-adult-women-who-have-limited-or-no