The November 11 issue of The New York Times included a story about a new drug for treatment of gonorrhea that has not yet been approved for use in any country but is expected to be a huge advance. No vaccine is available for prevention of gonorrhea, but the results of recent studies suggest that meningococcal B vaccine confers protection against the disease.1 (Neisseria meningitidis and Neisseria gonorrhoeae have similar genomes.)
The treatment of choice at the moment for uncomplicated urogenital, rectal, or pharyngeal gonorrhea is a single intramuscular injection of ceftriaxone or a large oral dose of cefixime, but over the years gonococci have developed resistance to penicillin, sulfonamides, tetracyclines, and fluoroquinolones and decreased susceptibility to azithromycin, ceftriaxone, and cefixime.
The new drug, zoliflodacin, is the first product of a new class of antibacterial agents called spiropyrimidinetriones. It is unlikely to suffer the same fate as the older drugs for treatment of gonorrhea because it has a much more powerful mechanism of action: it inhibits microbial biosynthesis. Zoliflodacin is active not only against ciprofloxacin-resistant and ceftriaxone-resistant N. gonorrhoeae, but also against fluoroquinolone-resistant and vancomycin-resistant-Staphylococcus aureus.2
In a phase 2 trial in 179 patients with gonorrhea, 2 grams of zoliflodacin cured 55 of 57 urogenital infections and 5 of 5 rectal infections, but only 4 of 8 pharyngeal infections. A 3-gram dose of the new drug cured 9 of 11 patients with pharyngeal infections.3 A phase 3 trial compared 3 grams of zoliflodacin with a combination of IM ceftriaxone and oral azithromycin in 930 patients with urogenital, rectal, or pharyngeal gonorrhea, including a higher percentage of women than in the phase 2 trial. Zoliflodacin met the prespecified test for noninferiority, according to a November 1, 2023 press release from the manufacturer.
More detailed information about the phase 3 results should be available soon, and FDA consideration for approval is expected to follow shortly.
- Bruxvoort KJ et al. Prevention of Neisseria gonorrhoeae with meningococcal B vaccine: a matched cohort study in Southern California. Clin Infect Dis 2023; 76:e1341. doi:10.1093/cid/ciac436
- PA Bradford et al. Zoliflodacin: an oral spiropyrimidinetrione antibiotic for the treatment of Neisseria gonorrheae, including multi-drug-resistant isolates. ACS Infect Dis 2020; 6:1332. doi:10.1021/acsinfecdis.0c00021
- SN Taylor et al. Single-dose zoliflodacin (ETX0914) for treatment of urogenital gonorrhea. N Engl J Med 2018; 379:1835. doi:10.1056/NEJMoa1706988
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