The US Food and Drug Administration (FDA) has approved two new oral medicines, Nuzolvence (zoliflodacin) and Blujepa (gepotidacin), to treat gonorrhea, a common sexually transmitted infection (STI) that is increasingly resistant to existing treatments. The World Health Organization (WHO) has classified the bacteria that causes gonorrhea, Neisseria gonorrhoeae, as a “high priority” pathogen due to its growing resistance to antibiotics. Gonorrhea is spread through sexual contact and can cause painful urination, bleeding, and discharge in the genital area, as well as infertility and complications if left untreated.
The two new drugs offer a critical addition to the limited treatment options available for gonorrhea. Nuzolvence, which is administered as a single oral dose, was developed by Entasis Therapeutics in partnership with the Global Antibiotic Research and Development Partnership (GARDP), a nonprofit organization. Blujepa, also an oral tablet, was developed by GSK. Indian pharmaceutical company Dr. Reddy’s is working to obtain market authorization for Nuzolvence in Thailand and South Africa, where clinical trials were conducted.
The WHO estimates that there were 82.4 million new cases of gonorrhea among adults aged 15-49 in 2020. The rise in cases is attributed in part to the increased use of Pre-Exposure Prophylaxis (PrEP) for HIV prevention, which does not protect against other STIs. The approval of these new drugs is a significant milestone in the treatment of gonorrhea, and GARDP is working to ensure that they are accessible to those who need them, particularly in low- and middle-income countries.
GARDP’s R&D Drug and Treatment Project Leader, Pierre Damar, notes that limiting the clinical use of zoliflodacin to treating gonorrhea will help to delay the emergence of resistance and prolong the effectiveness of the drug. The organization is exploring partnerships with governments and other stakeholders to ensure that the drug is available and accessible to those who need it. With the rise in gonorrhea cases, the approval of these new drugs is a crucial step in addressing this growing public health concern.