A new antibiotic has proven to be as effective as the previous recommended treatment for gonorrhea, helping to calm growing fears among public health experts about the emergence of drug-resistant strains of the sexually transmitted infection.
Gonorrhea is the second most common sexually transmitted infection (STI) in the United States and has developed resistance to all antibiotics used to treat it, except for the recommended combination therapy of injection of the antibiotic ceftriaxone with a single dose of azithromycin tablets. Has gone.
In recent years, some reports have suggested that this stock of antibiotics may no longer maintain their strong efficacy against rapidly evolving pathogens.
On Wednesday, results from a late-stage clinical trial of a new antibiotic called zoliflodacin showed that the drug cured so-called uncomplicated gonorrhea infections as effectively as ceftriaxone and azithromycin.
The drug was developed by the Global Antibiotic Research and Development Partnership, a Swiss non-profit, and US-based Innoviva Specialty Therapeutics.
“Zoliflodacin gives us a new tool in the treatment of gonorrhea and, if used wisely, it prevents resistant infections from spreading further,” said Dr. Jeffrey Klausner, an infectious disease specialist at the Keck School of Medicine at USC. “
The antibiotic, which would be the first new gonorrhea treatment approved in decades, could hit the market in 2025.
The World Health Organization estimates that there are more than 82 million new cases of gonorrhea each year globally.
In the United States, after decades of cuts to state and local public health departments, STIs have reached record levels. According to the Centers for Disease Control and Prevention, 710,151 cases of gonorrhea were diagnosed in 2021, a 28% increase from 2017.
This is a disease that is transmitted sexually.
Gonorrhea is spread through sexual contact and can infect the genitals, rectum, and throat separately.
STIs are especially common among adolescents and young adults and occur disproportionately in gay and bisexual men, the CDC reports.
If not treated, gonorrhea poses a risk of infertility and can be particularly harmful to women, causing pelvic inflammatory disease and ectopic pregnancy. Infection may also increase the risk of HIV transmission.
In recent years, global health authorities have issued increasingly urgent warnings that gonorrhea is gaining resistance to ceftriaxone and azithromycin, and cases of highly drug-resistant gonorrhea have been reported in several countries.
In January, the Massachusetts Department of Public Health reported the first two cases of gonorrhea in the United States that had resistance or reduced response to five classes of antibiotics.
A new report from the CDC shows that cases of sexually transmitted diseases have reached an all-time high for the sixth year in a row. The most recent figures are from 2019 and revealed more than 2.5 million cases of chlamydia, gonorrhea and syphilis. The sharpest rise in syphilis cases occurred among newborns, nearly quadrupling between 2015 and 2019.
Ceftriaxone cured those cases, but public health officials said it served as a precursor to the emergence of strains that could escape the antibiotic.
Without new antibiotic weapons, treating highly drug-resistant strains of gonorrhea may require intensive treatment with multiple antibiotics, according to Dr. Gene Marrazzo, director of the National Institute of Allergy and Infectious Diseases.
This so-called “kitchen sink approach” will strain medical resources and increase the risk of promoting the emergence of greater microbial resistance to those other antibiotics, he said.
The biggest fear is that gonorrhea may eventually become completely curable, at least in some people.
According to a representative of Innoviva, the company intends to apply to the Food and Drug Administration for approval of the antibiotic “as soon as possible.” Innoviva expects an expedited review, meaning it will take about six months for the FDA to issue a decision.
Zoliflodacin belongs to a new class of antibiotics and attacks gonorrhea in a new way. In previous laboratory studies, zoliflodacin was shown to be effective in neutralizing gonorrhea strains that were highly resistant to ceftriaxone and azithromycin and in strains that also had resistance to other antibiotics.
One downside to zoliflodasin is that a previous phase two clinical trial published in 2018 found that it was not as effective in treating gonorrhea infections in the throat as in the genital or rectal areas.
However, Marrazzo, a co-author of that study, said this disparity in gonorrhea treatments is common.
“Gonorrhea in the throat may become a major obstacle in our fight to control gonorrhea in the future,” Marrazzo said.
But the new zoliflodacin trial showed “encouraging” results in a small number of participants with rectal or throat infections, according to Dr. Margaret Koziel, Innoviva’s chief medical officer.
“The company will certainly consult with the FDA about whether the label indication could be for urogenital diseases or all uncomplicated gonorrhea,” Koziel said.