The U.S. Food and Drug Administration has approved two new oral antibiotics, zoliflodacin and gepotidacin, to treat uncomplicated gonorrhea infections. This development arrives as the sexually transmitted disease becomes increasingly resistant to existing treatments, threatening global health efforts.
The Growing Threat of Antibiotic Resistance
Neisseria gonorrhoeae, the bacteria causing gonorrhea, is notorious for its rapid ability to evolve and overcome drug therapies. Decades have passed since the last new antibiotics for this infection emerged, and the pathogen is now showing resistance to even the current primary treatment: the injectable drug ceftriaxone. This resistance is a critical concern, given that an estimated 82 million new cases of gonorrhea occur annually worldwide, with roughly 1.5 million in the U.S. alone.
Why it matters: Untreated gonorrhea can lead to serious complications, including pelvic inflammatory disease and infertility in women, blindness in newborns if transmitted during pregnancy, and painful symptoms or asymptomatic spread in men. The growing resistance undermines efforts to control the spread of this infection.
How the New Drugs Work
Both zoliflodacin and gepotidacin have demonstrated efficacy comparable to the standard ceftriaxone plus azithromycin treatment in phase 3 clinical trials published in The Lancet.
- Zoliflodacin blocks a protein crucial for bacterial function and reproduction, achieving similar eradication rates in trials as the existing dual-drug therapy.
- Gepotidacin inhibits bacterial replication of genetic material, also matching the performance of the current standard.
Common side effects reported in trials included headaches and nausea, though further study is needed to assess how well they work for women, as they were underrepresented in clinical trials (12% and 8% of participants respectively).
A Critical Step, But Not a Cure-All
These approvals represent a significant step forward, offering more options as the bacteria continues to evolve. However, the threat of resistance remains. The development of these drugs was partly funded by non-profit organizations like the Global Antibiotic Research & Development Partnership, highlighting the need for sustained investment in this area.
The reality is that gonorrhea will continue to adapt. Public health officials must continue monitoring resistance trends, encouraging safe sex practices, and supporting research into new therapies to stay ahead of this evolving pathogen.
