FDA OKs New Drug for Urinary Tract Infections

Oct. 28, 2024 — The FDA has approved Orlynvah, a new oral treatment for uncomplicated urinary tract infections (UTIs) in women who have limited options for effective antibiotic therapy.

Uncomplicated UTIs are bladder infections that typically affect women who don’t have other issues like kidney disease or urinary tract abnormalities. These infections are common, affecting around half of all women at least once in their lives.

Treating UTIs can be difficult when standard antibiotics don’t work well, often due to antibiotic resistance or certain health conditions. Orlynvah offers a promising new option by combining two drugs, sulopenem etzadroxil and probenecid, in one oral tablet. This combination helps keep the antibiotic in the body longer, making it work better, especially against bacteria that resist traditional treatments. Orlynvah is specifically approved to target infections from bacteria like E coli, Klebsiella pneumoniae, and Proteus mirabilis, which can be harder to treat.

Marjorie Golden, MD, an infectious disease specialist at Yale New Haven Hospital, described Orlynvah as a much-needed alternative for women struggling with difficult-to-treat UTIs.

“Orlynvah has the potential to be an important treatment option for those who need it,” she said in a news release from Iterum Therapeutics, the drug’s maker.

The FDA approved Orlynvah based on two large clinical trials involving over 3800 women. In these studies, Orlynvah worked as well as or better than antibiotics like ciprofloxacin and amoxicillin. It was generally well-tolerated, though common side effects included diarrhea, nausea, yeast infections, and headaches.

The FDA advises people to discuss their medical history with their doctor before taking Orlynvah, especially if they have conditions like gout, kidney stones, or allergies to other antibiotics.

SOURCES:

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

Iterum Therapeutics: “Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections.”

FDA Label: “ORLYNVAH (sulopenem etzadroxil and probenecid) tablets, for oral use.”

Clinical Infectious Diseases: “Sulopenem or Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infections in Women: A Phase 3, Randomized Trial.”