History of the discovery, development, and FDA-approval of buprenorphine medications for the treatment of opioid use disorder
Buprenorphine-based medications were first approved by the United States Food and Drug Administration in 2002 for the treatment of opioid dependence, or opioid use disorder (OUD) as the condition is presently known. This regulatory milestone was the outcome of 36 years of research and development, w...
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-03-01
|
| Series: | Drug and Alcohol Dependence Reports |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772724623000033 |
| _version_ | 1797867355989082112 |
|---|---|
| author | Christian Heidbreder Paul J. Fudala Mark K. Greenwald |
| author_facet | Christian Heidbreder Paul J. Fudala Mark K. Greenwald |
| author_sort | Christian Heidbreder |
| collection | DOAJ |
| description | Buprenorphine-based medications were first approved by the United States Food and Drug Administration in 2002 for the treatment of opioid dependence, or opioid use disorder (OUD) as the condition is presently known. This regulatory milestone was the outcome of 36 years of research and development, which also led to the development and approval of several other new buprenorphine-based medications. In this short review, we first describe the discovery and early development stages of buprenorphine. Second, we review key steps that led to the development of buprenorphine as a drug product. Third, we explain the regulatory approval of several buprenorphine-based medications for the treatment of OUD. We also discuss these developments in the context of the evolution of regulations and policies that have progressively improved OUD treatment availability and efficacy, although challenges remain in removing system-level, provider-level, and local-level barriers to quality treatment, to integrating OUD treatment into routine care and other settings, to reducing disparities in access to treatment, and to optimizing person-centered outcomes. |
| first_indexed | 2024-04-09T23:40:00Z |
| format | Article |
| id | doaj.art-ed50a4562a10446786fbf7f6b131e43f |
| institution | Directory Open Access Journal |
| issn | 2772-7246 |
| language | English |
| last_indexed | 2024-04-09T23:40:00Z |
| publishDate | 2023-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Drug and Alcohol Dependence Reports |
| spelling | doaj.art-ed50a4562a10446786fbf7f6b131e43f2023-03-19T04:39:01ZengElsevierDrug and Alcohol Dependence Reports2772-72462023-03-016100133History of the discovery, development, and FDA-approval of buprenorphine medications for the treatment of opioid use disorderChristian Heidbreder0Paul J. Fudala1Mark K. Greenwald2Indivior Plc, North Chesterfield, VA, United States of America; Corresponding author.Indivior Plc, North Chesterfield, VA, United States of AmericaDepartment of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, Detroit, Michigan, United States of AmericaBuprenorphine-based medications were first approved by the United States Food and Drug Administration in 2002 for the treatment of opioid dependence, or opioid use disorder (OUD) as the condition is presently known. This regulatory milestone was the outcome of 36 years of research and development, which also led to the development and approval of several other new buprenorphine-based medications. In this short review, we first describe the discovery and early development stages of buprenorphine. Second, we review key steps that led to the development of buprenorphine as a drug product. Third, we explain the regulatory approval of several buprenorphine-based medications for the treatment of OUD. We also discuss these developments in the context of the evolution of regulations and policies that have progressively improved OUD treatment availability and efficacy, although challenges remain in removing system-level, provider-level, and local-level barriers to quality treatment, to integrating OUD treatment into routine care and other settings, to reducing disparities in access to treatment, and to optimizing person-centered outcomes.http://www.sciencedirect.com/science/article/pii/S2772724623000033BuprenorphineFormulationsOpioid use disorderMedication developmentRegulatory approvals |
| spellingShingle | Christian Heidbreder Paul J. Fudala Mark K. Greenwald History of the discovery, development, and FDA-approval of buprenorphine medications for the treatment of opioid use disorder Drug and Alcohol Dependence Reports Buprenorphine Formulations Opioid use disorder Medication development Regulatory approvals |
| title | History of the discovery, development, and FDA-approval of buprenorphine medications for the treatment of opioid use disorder |
| title_full | History of the discovery, development, and FDA-approval of buprenorphine medications for the treatment of opioid use disorder |
| title_fullStr | History of the discovery, development, and FDA-approval of buprenorphine medications for the treatment of opioid use disorder |
| title_full_unstemmed | History of the discovery, development, and FDA-approval of buprenorphine medications for the treatment of opioid use disorder |
| title_short | History of the discovery, development, and FDA-approval of buprenorphine medications for the treatment of opioid use disorder |
| title_sort | history of the discovery development and fda approval of buprenorphine medications for the treatment of opioid use disorder |
| topic | Buprenorphine Formulations Opioid use disorder Medication development Regulatory approvals |
| url | http://www.sciencedirect.com/science/article/pii/S2772724623000033 |
| work_keys_str_mv | AT christianheidbreder historyofthediscoverydevelopmentandfdaapprovalofbuprenorphinemedicationsforthetreatmentofopioidusedisorder AT pauljfudala historyofthediscoverydevelopmentandfdaapprovalofbuprenorphinemedicationsforthetreatmentofopioidusedisorder AT markkgreenwald historyofthediscoverydevelopmentandfdaapprovalofbuprenorphinemedicationsforthetreatmentofopioidusedisorder |