The US Food & Drug Administration (FDA) has given the green light to zoliflodacin (Nuzolvence) as an oral treatment for gonorrhoea, a day after approving oral gepotidacin (Bluejepa) for the same indication, reports Medpage Today.
Zoliflodacin is the first of a new class of antibiotics, called spiropyrimidinetriones, that have activity against Neisseria gonorrhoeae. The FDA approved zoliflodacin for the treatment of uncomplicated urogenital gonorrhoea caused by N. gonorrhoeae in adults and paediatric patients aged 12 and older who weigh at least 34kg.
“The availability of additional treatment options is particularly important, given the global rise in gonococcal drug resistance,” said Peter Kim, MD, director of the Division of Anti-infectives at FDA’s Centre for Drug Evaluation and Research.
“This approval marks a huge turning point in the treatment of multidrug-resistant gonorrhoea, which until now has been outpacing antibiotic development,” said Manica Balasegaram, MD, executive director of the Global Antibiotic Research and Development Partnership (GARDP) in Geneva.
GARDP developed zoliflodacin in partnership with Innoviva Specialty Therapeutics, and the two share commercial rights.
FDA approval was based on a randomised phase 111 trial that found zoliflodacin was non-inferior to standard therapy with ceftriaxone plus azithromycin in treating uncomplicated urogenital gonorrhoea.
Among more than 900 patients, the microbiological cure rate was 90.9% among those who received one dose of oral zoliflodacin compared with 96.2% for those who received intramuscular ceftriaxone plus oral azithromycin.
The estimated difference between the two groups was 5.3% in the microbiological intention-to-treat analysis, with an upper confidence interval of 10.2%, which met the study’s non-inferiority threshold of less than a 12% difference. Each treatment group reported 46% of patients had at least one treatment-emergent adverse event, although most were either mild or moderate.
Innoviva said it planned to bring zoliflodacin to the US market in the second half of 2026.
Zoliflodacin’s developers plan to focus exclusively on the indication for the treatment of gonorrhoea, limiting its clinical use to that condition to slow the rise of antimicrobial resistance.
There were an estimated 82.4m new gonorrhoea infections among adults globally in 2020, according to the World Health Organisation. Provisional data from the CDC showed that 543 000 cases were reported among US adults last year.
Medpage Today article – Second Oral Antibiotic for Gonorrhoea Gets FDA Green Light (Open access)
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