The US Food and Drug Administration (FDA) has accepted British pharmaceutical company GSK’s application for priority review of gepotidacin as an oral option for uncomplicated gonorrhoea infections, the company said last week.
CIDRAP reports that gepotidacin is a first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by targeting a distinct binding site. In March, the FDA approved the antibiotic for treatment of uncomplicated urinary tract infections.
But GSK, which developed gepotidacin in collaboration with the American government’s Biomedical Advanced Research and Development Authority, has also been evaluating its potential as a treatment for uncomplicated gonorrhoea.
The company’s supplemental New Drug Application was supported by data from the EAGLE-1 Trial, which involved more than 600 people with Neisseria gonorrhoeae infections in five countries.
The results showed that two doses of oral gepotidacin were non-inferior to the standard regimen of intramuscular ceftriaxone plus oral azithromycin, with a treatment success rate of 93% and no new safety concerns.
Vital new treatment option
If gepotidacin is approved for gonorrhoea, it would be a much-needed new option for the sexually transmitted bacterium, which causes more than 82m infections globally each year.
Ceftriaxone is the last remaining empiric treatment option for N gonorrhoeae, a bacterium that has quickly developed resistance to every antibiotic that’s been used for treatment. But resistance to ceftriaxone is already high in parts of Asia and has been spreading to other parts of the world.
GSK also noted that injectable ceftriaxone may not be suitable for all patients.
The threat of untreatable gonorrhoea, which can cause pelvic inflammatory disease, ectopic pregnancy, and infertility in women, has led the WHO and the US Centres for Disease Control and Prevention (CDC) to label drug-resistant N gonorrhoeae a serious and urgent public health threat.
The last new antibiotic for gonorrhoea was introduced in the 1990s.
GSK said the FDA has set a target date of 11 December 2025 for its decision.
CIDRAP article – FDA grants priority review for new oral gonorrhoea antibiotic (Open access)
See more from MedicalBrief archives:
UTI drug offers hope as new gonorrhoea treatment – global study
Concern as ‘super-strength’ gonorrhoea gets more drug resistant