National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD 20892, USA.
Food and Drug Administration, Silver Spring, MD 20892, USA.
Sci Transl Med. 2018 Mar 28;10(434). doi: 10.1126/scitranslmed.aan2595.
The FDA's "abstinence" outcome measure for approval of new medications to treat opioid-use disorders has been difficult to achieve; developing and validating alternative meaningful outcomes could facilitate drug development.
美国食品和药物管理局(FDA)批准新药物治疗阿片类药物使用障碍的“戒除”结果衡量标准一直难以实现;开发和验证替代有意义的结果可以促进药物开发。