The U.S. Food and Drug Administration (FDA) has approved two new oral antibiotics, zoliflodacin and gepotidacin, to treat gonorrhea infections. This development comes amid growing concerns over the increasing drug resistance of the pathogen Neisseria gonorrhoeae, which has not seen a new class of antibiotics for decades. The approval is a significant step in addressing a public health challenge that affects millions globally.
Both medications are effective for treating gonorrhea infections of the urethra or cervix that have not disseminated to other parts of the body. The need for new treatment options is underscored by the pathogen’s resistance to many existing antibiotics, including the commonly used injectable drug ceftriaxone. Resistance to ceftriaxone is particularly alarming, as it threatens to undermine efforts to control the estimated 82 million new cases of gonorrhea reported worldwide in 2020.
In the United States, approximately 1.5 million new gonorrhea infections occur each year, with around 550,000 cases reported annually. Symptoms in men often include painful urination, but many women remain asymptomatic, potentially leading to severe complications such as pelvic inflammatory disease or infertility. Pregnant individuals risk passing the infection to newborns, which can result in serious health issues, including blindness, if left untreated.
Clinical Trial Results and Development Background
The FDA’s approval of zoliflodacin and gepotidacin follows promising results from phase 3 clinical trials. A study published in The Lancet on December 11, 2022, indicated that zoliflodacin effectively eradicated the bacteria in a comparable proportion of participants to those treated with ceftriaxone and the antibiotic azithromycin. Zoliflodacin operates by blocking a protein essential for bacterial function and reproduction.
In May 2023, another study published in The Lancet reported on gepotidacin, which has already been approved for treating urinary tract infections. This antibiotic works by inhibiting the bacterial replication of genetic material and demonstrated efficacy similar to that of ceftriaxone combined with azithromycin.
Both antibiotics have shown a manageable side effect profile, with headaches and nausea being the most common complaints reported by trial participants. However, further research is necessary to understand their effectiveness specifically in women, as the representation of female participants in clinical trials was low—only 12 percent in the zoliflodacin trial and 8 percent in the gepotidacin trial.
Implications for Public Health
The introduction of zoliflodacin and gepotidacin into the treatment arsenal represents a significant advancement in the fight against gonorrhea. This development is particularly critical given the rising rates of antibiotic resistance that jeopardize public health efforts. The nonprofit Global Antibiotic Research & Development Partnership played a vital role in the development of zoliflodacin, highlighting the importance of collaboration between the public and private sectors in addressing global health challenges.
As healthcare providers begin to incorporate these new antibiotics into treatment regimens, ongoing surveillance and research will be essential to ensure their effectiveness and monitor for potential resistance. The approval of these medications marks an important milestone in addressing a disease that continues to pose a significant threat to sexual health worldwide.
