University of Virginia, Charlottesville, VA, USA.
University of Virginia, Charlottesville, VA, USA.
Sex Med Rev. 2017 Oct;5(4):461-469. doi: 10.1016/j.sxmr.2017.06.003. Epub 2017 Jul 27.
The process of approval for flibanserin (trade name Addyi) has been associated with controversy since before its approval on August 18, 2015. This argument centered on challenges to the validity of the diagnosis of hypoactive sexual desire disorder in women and the safety and efficacy of the drug.
To explore the process of Food and Drug Administration (FDA) approval for flibanserin and delve further into the research, concerns, and various roadblocks to its approval.
A literature review was undertaken using the terms flibanserin and hypoactive sexual desire disorder and relevant commentary from supporters and critics regarding the medication and difficulties leading up to approval.
Review of the process of FDA approval of a medication to treat hypoactive sexual desire disorder and research published exploring the efficacy and safety of flibanserin.
Before flibanserin, there were no drugs approved to treat hypoactive sexual desire disorder, which has a reported estimated incidence of 10% of women. For studying the effectiveness of flibanserin, the FDA required satisfying sexual events as the primary end point, although this end point does not measure level of desire or the associated distress. The satisfying sexual event measurement was significant across all three flibanserin trials in premenopausal women, as was an increase in desire according to the Female Sexual Function Index desire domain and a decrease in distress as recorded with the Female Sexual Distress Scale-Revised, Item 13. Safety concerns centered on the incidence of sedation, syncope, hypotension, and the interaction of flibanserin with alcohol and CYP3A4 inhibitors. Additional targeted challenge studies were mandated by the FDA.
The process of approval of flibanserin was lengthy. This was due in part to it being the first drug in its class and one with no clear guidance on study design from the FDA or roadmap for development and approval. Dooley EM, Miller MK, Clayton AH. Flibanserin: From Bench to Bedside. Sex Med Rev 2017;5:461-469.
自 2015 年 8 月 18 日批准以来，氟班色林（商品名 Addyi）的批准过程一直存在争议。这场争论的焦点是对女性性欲低下障碍诊断的有效性以及药物的安全性和有效性提出质疑。
探索食品和药物管理局 (FDA) 对氟班色林的批准过程，并深入研究该药物的研究、关注点以及其批准面临的各种障碍。
使用氟班色林和性欲低下障碍这两个术语，以及支持者和批评者关于该药物的相关评论，对文献进行了回顾，并对导致批准的困难进行了研究。
审查 FDA 批准治疗性欲低下障碍药物的过程，以及研究氟班色林的功效和安全性的研究。
在氟班色林之前，没有药物被批准用于治疗性欲低下障碍，这种疾病据报道发病率为 10%的女性。为了研究氟班色林的有效性，FDA 要求以满意的性事件作为主要终点，尽管这一终点并不能衡量欲望水平或相关的痛苦程度。在所有三项氟班色林试验中，绝经前妇女的满意性事件测量都具有统计学意义，根据女性性功能指数欲望域，欲望增加，而女性性功能障碍量表修订版第 13 项记录的痛苦程度降低。安全性问题集中在镇静、晕厥、低血压以及氟班色林与酒精和 CYP3A4 抑制剂的相互作用上。FDA 还要求进行额外的有针对性的挑战研究。
氟班色林的批准过程漫长。部分原因是它是同类药物中的第一种药物，而且 FDA 没有关于研究设计的明确指导或开发和批准的路线图。
