美國食品藥品管理局（Food and Drug Administration，F(xiàn)DA）于2022年2月發(fā)布了“用于急性疼痛的非阿片類鎮(zhèn)痛藥的開發(fā)供企業(yè)用的指導(dǎo)原則草案”，旨在幫助申請人開發(fā)用于治療持續(xù)30 d的急性疼痛的阿片類藥物替代品，促進(jìn)這類藥物的發(fā)展，減少阿片類藥物的使用，對抗阿片類藥物的誤用、濫用和成癮。該指導(dǎo)原則闡述了FDA目前對下列3方面的具體看法：用于急性疼痛的非阿片類鎮(zhèn)痛藥的臨床試驗(yàn)方案、其說明書中關(guān)于消除或減少阿片類藥物使用的描述以及這類藥物的加快審批程序。重點(diǎn)是前兩者，尤其是臨床試驗(yàn)方案。而中國目前還沒有類似的指導(dǎo)原則，詳細(xì)介紹該指導(dǎo)原則，期望對中國這類藥物的臨床研究及其監(jiān)管有所幫助。

FDA issued the Development of Non-Opioid Analgesics for Acute Pain Draft Guidance for Industry in February 2022, which aims to help sponsors develop opioid alternatives for the treatment of acute pain lasting for 30 days, promote the development of such drugs, reduce the use of opioids and combat the misuse, abuse and addiction of opioids. The guidance set forth FDA's current specific thinking about the following three aspects: the clinical trial program of non-opioid analgesics for acute pain, the claims of eliminating or reducing the use of opioids in its labeling, and the expedited review programs of such drugs. The focus is on the first two, especially the clinical trial program. At present, there is no similar guidance in China. This paper introduces the guidance in detail, and looks forward to being helpful to the clinical research and supervision of this kind of drugs in China.

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