The US Food and Drug Administration (FDA) has approved two new antibiotics for the treatment of gonorrhea, marking a significant development amid a rising trend of drug-resistant cases of the sexually transmitted infection, reports BritPanorama.
The FDA announced on Friday the approval of zoliflodacin, marketed as Nuzolvence, designed as a single-dose oral treatment for gonorrhea affecting the urogenital area in adults and adolescents aged 12 and above who weigh at least 77 pounds. The drug, developed in collaboration by the Global Antibiotic Research and Development Partnership and Innoviva Specialty Therapeutics Inc., is administered as dissolvable granules.
In a related development, GSK revealed on Thursday that the FDA had also approved gepotidacin, branded as Blujepa, for the same demographic. This medication is an oral tablet intended for treating urogenital gonorrhea in individuals 12 and older weighing at least 99 pounds, especially those with limited treatment options. Gepotidacin was previously approved in March for urinary tract infections in women.
“These approvals mark a significant milestone for treatment options for patients with uncomplicated urogenital gonorrhea,” said Dr. Adam Sherwat, director of the Office of Infectious Diseases at the FDA’s Center for Drug Evaluation and Research, in a news release. The urgency of these approvals stems from the accelerated emergence of resistance among Neisseria gonorrhoeae, the bacterium causing gonorrhea, against many standard treatment protocols.
Effective treatment alternatives have dwindled in recent years as the bacteria have shown resistance to previously reliable antibiotics. Current treatment has largely relied on ceftriaxone injections, necessitating patients to visit clinics for care.
In contrast, both newly sanctioned antibiotics can be taken orally, thus reducing the need for clinic visits and the associated inconvenience. “Zoliflodacin is a single-dose treatment, which also gives it a big advantage,” said Dr. Manica Balasegaram, executive director of the Global Antibiotic Research and Development Partnership. This feature enhances its applicability across various healthcare settings without the need for injection facilities.
The FDA’s actions reflect an pressing necessity in the U.S., where reported cases of sexually transmitted infections—including chlamydia, gonorrhea, and syphilis—have surged by approximately 90% from 2004 to 2023. Over 2.4 million STI cases were recorded in 2023 alone, according to data released by the US Centers for Disease Control and Prevention (CDC).
Untreated gonorrhea can lead to severe health complications, including pelvic inflammatory disease in women, which raises the risk of infertility and pregnancy complications, and can also pose long-term infertility risks in men. The absence of a vaccine further complicates the public health challenge posed by this infection.
Dr. David Altarac, chief medical officer at Innoviva Specialty Therapeutics, noted that zoliflodacin was engineered to maintain efficacy against resistant strains of Neisseria gonorrhoeae that exhibit reduced responsiveness to traditional antibiotics. The introduction of zoliflodacin and gepotidacin is a timely response to a growing health crisis, yet experts emphasize the importance of ongoing research and development to secure future treatment options.
Promising results from clinical trials indicated that a single oral dose of zoliflodacin performed comparably to the current standard treatment, showing an efficacy of approximately 90.9% compared to 96.2% for the standard approach. Additionally, the recent trials suggested both treatments exhibited predictable safety profiles, with most reported side effects classified as mild or moderate.
Innoviva’s CEO Pavel Raifeld highlighted the company’s commitment to affordable access for patients globally, with detailed pricing expected to be announced later. Meanwhile, the urgency remains as the medical community navigates the complex landscape of emerging antibiotic resistance in gonorrhea treatment.
As the landscape of gonorrhea treatment shifts with new developments, a focused commitment to continued research and innovation in antibiotic therapies remains imperative.
