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FDA Approves Two First-in-Class Oral Treatments for Gonorrhea

The decisions introduce new mechanisms after years of reliance on ceftriaxone, with use restrictions and safety precautions designed to guide stewardship.

**ONE TIME USE LICENSE**Gonorrhoea bacteria. Coloured scanning electron micrograph (SEM) of gonorrhoea bacteria (Neisseria gonorrhoeae, round) on a human epithelial cell. Gonorrhoea is a venereal (sexually-transmitted) disease. Infection is of the urethra, causing a discharge of yellow fluid. It readily spreads to surrounding tissues. If it spreads further to the blood or brain, it may be fatal. Treatment is with antibiotic drugs.
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Effective treatment options for gonorrhea have been shrinking fast in recent years as the bacteria responsible for the infection, Neisseria gonorrhoeae, develops resistance to many of the medications widely used to treat it.
Reported cases of three sexually transmitted infections – chlamydia, gonorrhea and syphilis – jumped 90% in 2023 compared with about two decades prior in 2004, according to CDC data.

Overview

  • The FDA cleared GSK’s Blujepa (gepotidacin) for uncomplicated urogenital gonorrhea in patients 12 or older weighing at least 45 kg, with labeling that limits use to those with limited or no alternative options to standard care.
  • Innoviva’s Nuzolvence (zoliflodacin) won approval as a single‑dose oral therapy for patients 12 or older weighing at least 35 kg, expanding options beyond the current injectable standard.
  • Phase 3 trials published in The Lancet showed noninferiority: gepotidacin achieved a 92.6% urogenital cure rate versus 91.2% with ceftriaxone plus azithromycin, and zoliflodacin achieved 90.9% versus 96.2% for the comparator regimen.
  • Safety profiles differed: gepotidacin’s most common effects were gastrointestinal and generally mild to moderate, while zoliflodacin’s label lists headache, dizziness, nausea, diarrhea, low white blood cell counts, and animal‑study signals prompting pregnancy and fertility precautions.
  • Approvals currently cover urogenital infection; trial data showed comparable outcomes at extragenital sites, and Innoviva said U.S. availability of Nuzolvence is expected next year as companies and regulators emphasize antimicrobial stewardship.