Medication development in opioid addiction: Meaningful clinical end points

Nora D Volkow; Janet Woodcock; Wilson M Compton; Douglas C Throckmorton; Phil Skolnick; Sharon Hertz; Eric M Wargo

doi:10.1126/scitranslmed.aan2595

Medication development in opioid addiction: Meaningful clinical end points

Sci Transl Med. 2018 Mar 28;10(434):eaan2595. doi: 10.1126/scitranslmed.aan2595.

Authors

Nora D Volkow¹, Janet Woodcock², Wilson M Compton³, Douglas C Throckmorton², Phil Skolnick³, Sharon Hertz², Eric M Wargo³

Affiliations

¹ National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD 20892, USA. nvolkow@nida.nih.gov.
² Food and Drug Administration, Silver Spring, MD 20892, USA.
³ National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD 20892, USA.

PMID: 29593105
DOI: 10.1126/scitranslmed.aan2595

Abstract

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.

Publication types

Review

MeSH terms

Drug Approval / statistics & numerical data
Drug Development / statistics & numerical data
Humans
Opioid-Related Disorders / drug therapy*
Opioid-Related Disorders / prevention & control*
United States
United States Food and Drug Administration