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The Food and Drug Administration has approved 2 new oral antibiotics for the treatment of uncomplicated gonorrhea, expanding therapeutic options amid growing drug resistance. Zoliflodacin was approved based on results from a multinational phase 3 trial involving 930 patients. In the study, a single oral dose of zoliflodacin was noninferior to a regimen of injectable ceftriaxone plus oral azithromycin. The study showed 91% of patients who took zoliflodacin were cured, and 96% of patients who received the standard treatment were cured, indicating comparable effectiveness. Zoliflodacin is approved for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients aged 12 years and older who weigh at least 77 pounds. It will be marketed under the brand name Nuzolvence. The FDA also approved gepotidacin for the treatment of uncomplicated gonorrhea. Gepotidacin, marketed as Bluejepa, was previously approved for uncomplicated urinary tract infections. Its approval for gonorrhea was supported by a phase 3 trial of 628 patients, in which gepotidacin demonstrated noninferiority to ceftriaxone plus azithromycin. Cure rates were comparable at 93% in the gepotidacin group and 91% in the standard-treatment group.
Cautious optimism: The availability of these oral agents is expected to help address rising resistance to ceftriaxone, which has been a standard in gonorrhea treatment for decades. Even so, the problem of antibiotic-resistant gonorrhea will likely continue because N. gonorrhoeae is likely to keep evolving, researchers say. An estimated 82 million new gonorrhea infections occur globally each year.