Single-Dose Pill Shows Promise Against Antibiotic-Resistant Gonorrhoea
In an international phase 3 trial, oral zoliflodacin showed a 90.9% cure rate for urogenital gonorrhea, comparable to 96.2% with standard injectable treatment, addressing rising antibiotic resistance.
- On Thursday, an international phase III trial showed investigational oral zoliflodacin noninferior to intramuscular ceftriaxone plus oral azithromycin for uncomplicated urogenital gonorrhea, with a 90.9% cure rate among over 900 patients, Alison Luckey of the Global Antibiotic Research & Development Partnership reported.
- Practical barriers to injectable ceftriaxone, such as clinics not stocking it, prompted the search for oral options, with WHO data showing about 5.3% ceftriaxone resistance across 12 countries in 2024.
- Laboratory and trial surveillance found the trial cohort of 930 randomized patients met noninferiority metrics with a 5.3% estimated difference, upper CI 10.2%, and zoliflodacin resistance did not develop during the trial.
- If regulators approve the drug, zoliflodacin could expand access, slow resistant infections, and protect reproductive health, with UK, Europe and Asia approvals probably following soon, says Charlotte-Eve Short at Imperial College London.
- Researchers cautioned the open-label design and limited female and adolescent enrollment restrict generalizability, and urged enhanced global monitoring of gonococcal resistance due to rapid bacterial evolution.
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A single-dose oral drug called zoliflodacin is promising as a new treatment for antibiotic-resistant gonorrhea, according to a phase 3 clinical trial published by a team of international researchers from the United States, Europe, South Africa and Thailand, led by the University of Alabama at Birmingham, United States, at The Lancet. The study found that a dose of zoliflodacin was as effective as the current standard treatment, combining two ant…
New antibiotic could stave off drug-resistant gonorrhoea
Neisseria gonorrhoeae, the microbe responsible for gonorrhoea, is developing resistance to most antibiotics, which means we need new drugs to treat the condition. An antibiotic called zoliflodacin might be part of a solution
Novel Oral Antibiotic Matches Standard Option for Urogenital Gonorrhea
(MedPage Today) -- Investigational zoliflodacin was noninferior to standard therapy with ceftriaxone plus azithromycin in treating uncomplicated urogenital gonorrhea, an international phase III randomized trial showed. Among over 900 patients...
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