New Antibiotic, Zoliflodacin, Seeking Approval, Tackles Drug-Resistant Gonorrhea in Trial

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Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 3, 2023.

By Cara Murez HealthDay Reporter

FRIDAY, Nov. 3, 2023 -- The first new antibiotic for gonorrhea — the second most common sexually transmitted disease — has shown promise in a clinical trial.

That news should come as a relief to public health experts, because gonorrhea has become resistant to all but one of the existing antibiotics used to treat it.

This new antibiotic, called zoliflodacin, was seen in the trial to cure uncomplicated gonorrhea infection as effectively as the current go-to, which is an injection of the antibiotic ceftriaxone along with one dose of azithromycin pills.

Some have been concerned that the combo won’t maintain its effectiveness, leaving all gonorrhea without a treatment, NBC News reported.

“Zoliflodacin gives us a new tool in the treatment of gonorrhea, and if used wisely, a barrier against the further spread of resistant infections,” Dr. Jeffrey Klausner, an infectious disease expert at the Keck School of Medicine at University of Southern California, told NBC News.

The drug was developed by U.S.-based Innoviva Specialty Therapeutics and Swiss nonprofit Global Antibiotic Research & Development Partnership.

“The outcome of this study is a potential game changer for sexual health," Dr. Edward Hook III, protocol chair for the study and emeritus professor of medicine at the University of Alabama, said in a news release from the drug's developers.

“In addition to the potential benefits for patients with infections with resistant strains of Neisseria gonorrhoeae, the potential lack of cross-resistance with other antibiotics and the oral route of administration will simplify gonorrhea therapy for clinicians worldwide,” Hook added.

Zoliflodacin treats gonorrhea in a new way. However, it’s less effective at treating gonorrhea infection of the throat than it is in the genital or rectal areas, NBC News reported.

That is known to be common among all gonorrhea treatments.

“Gonorrhea in the throat is probably going to be a major Achilles heel in our battle to control gonorrhea going forward,” said study co-author Dr. Jeanne Marrazzo, director of the U.S. National Institute of Allergy and Infectious Diseases.

Innoviva said it expects to seek U.S. Food and Drug Administration approval “as quickly as practicably possible.”

There are more than 82 million new gonorrhea cases each year, according to the World Health Organization (WHO). Cases surged to more than 710,000 in 2021 in the United States, a 28% increase from 2017, according to the U.S. Centers for Disease Control and Prevention.

Gonorrhea is spread through sexual contact, and is particularly common in young adults and adolescents. It is seen disproportionately in gay and bisexual men, according to the CDC.

The infection raises the risk of HIV infection, and can be especially damaging to women and can compromise fertility.

The Massachusetts Department of Public Health in January reported the first two U.S. cases of gonorrhea with resistance or reduced response to five classes of antibiotics, NBC News reported. Luckily, those cases were cured by ceftriaxone.

The zoliflodacin study enrolled 930 men, women and adolescents, including those with HIV, at 16 trial sites in five countries. The patients in Belgium, the Netherlands, South Africa, Thailand and the United States were randomly assigned to either a single oral dose of zoliflodacin or a ceftriaxone injection plus oral azithromycin.

The emergence of drug-resistant pathogens are one of the top 10 global public health threats, according to the WHO.

Sources

  • NBC News, Nov. 3, 2023

    • Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

    Posted : 2023-11-06 15:07

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