Abstract：
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.
摘要：
对开发治疗淋病的药物的需求尚未满足，由于淋病奈瑟菌对用于经验性治疗的抗菌药物的耐药性迅速发展，全球报告的耐多药病例增加，和有限的可用治疗选择。此外，很少有药物正在开发中。临床试验设计中的挑战阻碍了抗菌药物的发展，可用诊断的限制，护理标准的变化和变化，缺乏健壮的动物模型，和临床相关的药效学目标。2021年4月23日，美国食品和药物管理局；疾病控制和预防中心；国家过敏和传染病研究所，美国国立卫生研究院与学术界的利益相关者共同主办了一个研讨会，工业,和监管机构讨论挑战和策略，包括潜在的合作和激励措施，以促进治疗淋病的药物的开发。本文提供了研讨会的摘要。
