The U.S. Food and Drug Administration has approved two new oral medicines for the treatment of uncomplicated urogenital gonorrhea, marking an important regulatory step as FDA approval for gonorrhea medications expands treatment options for a common sexually transmitted infection amid rising antimicrobial resistance. The approvals cover Nuzolvence (zoliflodacin) granules that dissolve in water and Blujepa (gepotidacin) oral tablets, expanding options beyond injectable regimens for eligible patients aged 12 years and older who meet specific weight thresholds. Nuzolvence is approved for adults and children weighing at least 77 pounds, while Blujepa is indicated for patients weighing at least 99 pounds who have few or no alternative treatment choices due to limited clinical safety data. Blujepa had previously received approval for the treatment of urinary tract infections.
“These approvals mark a significant milestone for treatment options for patients with uncomplicated urogenital gonorrhea,” said Adam Sherwat, M.D., director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research (CDER). Gonorrhea, caused by the bacterium Neisseria gonorrhoeae (N. gonorrhoeae), is a localized infection of the urethra or cervix that can lead to painful urination, discharge, and swelling, and may progress to infertility if left untreated. As the FDA approves two oral therapies, the agency highlighted the importance of expanding treatment choices as clinical practice has shifted from combination therapy with ceftriaxone and azithromycin to reliance on a single ceftriaxone injection.
Approval of Nuzolvence was supported by a study involving 930 patients with uncomplicated urogenital gonorrhea. Two-thirds of participants received a single 3-gram dose of Nuzolvence dissolved in water, while the remaining patients received standard treatment consisting of a ceftriaxone shot and an azithromycin pill. Bacterial clearance assessed 4 to 8 days after treatment showed cure rates of 91% for Nuzolvence and 96% for standard treatment, demonstrating comparable effectiveness. Blujepa was evaluated in a separate study of 628 patients, where participants received either two 3,000 mg doses taken 10 to 12 hours apart or standard therapy. Clearance rates assessed 4 to 10 days after treatment showed cure rates of 93% for Blujepa and 91% for standard treatment.
The safety results were in line with what is already known about both drugs. The most common adverse events reported with Nuzolvence included low white blood cell counts, headache, dizziness, nausea, and diarrhea, while Blujepa’s most frequently reported side effects included gastrointestinal symptoms, headache, fatigue, excessive sweating, and dizziness, with warnings related to heart rhythm effects, acetylcholinesterase inhibition, and allergic reactions. Both therapies received Fast Track, Qualified Infectious Disease Product, and Priority Review designations. As part of the FDA approval for gonorrhea medications, approval of Nuzolvence was granted to Entasis Therapeutics, while approval for Blujepa was granted to GSK.
