The U.S. Food and Drug Administration has approved two new oral medications for the treatment of uncomplicated urogenital gonorrhea, expanding options beyond the traditional injectable antibiotic regimen.
The first, Nuzolvence(zoliflodacin), is a single-dose oral therapy that dissolves in water and is approved for adults and children aged 12 and older who meet weight criteria. The second, Blujepa (gepotidacin), received FDA approval a day earlier as an oral option for patients aged 12 and above with limited or no alternative treatment choices.
Gonorrhea is caused by the bacterium Neisseria gonorrhoeae and can lead to painful symptoms at urogenital sites, with the potential for more serious reproductive health complications if left untreated.
Historically, the infection has been treated with an injectable antibiotic, ceftriaxone, sometimes in combination with an oral antibiotic; recent clinical guidelines have emphasized the injectable alone. The new approvals come amid rising concerns about antibiotic resistance in gonorrhea.
Clinical trials for Nuzolvence showed cure rates comparable to the standard treatment in patients with uncomplicated urogenital gonorrhea, with about nine in ten participants achieving bacterial clearance. Blujepa’s pivotal studies also demonstrated effectiveness similar to existing treatment regimens. Both therapies showed side effects typical of systemic antibiotics, including gastrointestinal symptoms and dizziness, and come with labelled safety precautions.
The FDA granted both medicines designations such as Fast Track, Qualified Infectious Disease Product, and Priority Review to accelerate their development and review. Nuzolvence was approved for Entasis Therapeutics, while Blujepa received approval under its supplemental application for gepotidacin from GSK.
The approvals mark a significant expansion in oral treatment options for gonorrhea, an infection that remains a priority public health challenge.
