Opioid use disorder: endpoints for demonstrating effectiveness of drugs for treatment

Opioid use disorder: endpoints for demonstrating effectiveness of drugs for treatment

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Language(s):
English
Format:
Text
Subject(s):
Analgesics, Opioid
Opioid-Related Disorders -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This guidance is intended to help sponsors develop drugs for treatment of opioid use disorder (OUD). This guidance addresses clinical endpoints acceptable for demonstrating effectiveness of such drugs. This guidance does not address the development of drugs intended only to provide symptomatic relief of opioid withdrawal. For assistance on specific drug development programs to treat OUD, sponsors should contact the Division of Anesthesiology, Addiction Medicine, and Pain Medicine (the division) in the Center for Drug Evaluation and Research.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (6 pages)).
NLM Unique ID:
9918231297206676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918231297206676