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US Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health Co-Sponsored Public Workshop Summary-Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea
Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
Office of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, MD, USA.
Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
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2025 (English)In: Clinical Infectious Diseases, ISSN 1058-4838, E-ISSN 1537-6591, Vol. 81, no 6, p. 1201-1208Article in journal (Refereed) Published
Abstract [en]

There is an unmet need for developing drugs for the treatment of gonorrhea, due to rapidly evolving resistance of Neisseria gonorrhoeae against antimicrobial drugs used for empiric therapy, an increase in globally reported multidrug resistant cases, and the limited available therapeutic options. Furthermore, few drugs are under development. Development of antimicrobials is hampered by challenges in clinical trial design, limitations of available diagnostics, changes in and varying standards of care, lack of robust animal models, and clinically relevant pharmacodynamic targets. On April 23, 2021, the U.S. Food and Drug Administration; Centers for Disease Control and Prevention; and National Institute of Allergy and Infectious Diseases, National Institutes of Health co-sponsored a workshop with stakeholders from academia, industry, and regulatory agencies to discuss the challenges and strategies, including potential collaborations and incentives, to facilitate the development of drugs for the treatment of gonorrhea. This article provides a summary of the workshop.

Place, publisher, year, edition, pages
University of Chicago Press, 2025. Vol. 81, no 6, p. 1201-1208
Keywords [en]
Antimicrobial drugs, antimicrobial resistance, drug development, gonorrhea, unmet need
National Category
Pharmacology and Toxicology Infectious Medicine
Identifiers
URN: urn:nbn:se:oru:diva-115413DOI: 10.1093/cid/ciae386ISI: 001303488300001PubMedID: 39045871OAI: oai:DiVA.org:oru-115413DiVA, id: diva2:1891141
Funder
Wellcome trust, WT224842
Note

This workshop was supported by the Center for Drug Evaluation and Research, US Food and Drug Administration. Research on Debio 1453 reported in this article is supported by CARB-X. CARB-X’s funding for this project is provided in part by federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (agreement 75A50122C00028). It is also supported by awards from the Wellcome Trust (WT224842) and the Federal Ministry of Education and Research (BMBF) of the Federal Republic of Germany. 

Available from: 2024-08-21 Created: 2024-08-21 Last updated: 2026-03-06Bibliographically approved

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