The history of the development of buprenorphine as an addiction therapeutic

Abstract

This paper traces the early 21st century success of the agonist-antagonist buprenorphine and the combination drug buprenorphine with naloxone within the broader quest to develop addiction therapeutics that began in the 1920s as the search for a nonaddictive analgesic. Drawing on archival research, document analysis, and interviews with contemporary actors, this paper situates the social organization of laboratory-based and clinical research within the domestic and international confluence of several issues, including research ethics, drug regulation, public attitudes, tensions around definitions of drug addiction, and the evolving roles of the pharmaceutical industry. The fervor that drove the champions of buprenorphine must be understood in relation to (1) the material work of research and pharmaceutical manufacturing; (2) the symbolic role of buprenorphine as a solution to numerous problems with addiction treatment evident by the mid-1970s; the destigmatization and individualization of addicts as patients; and (3) the complex configurations of public and private partnerships.

Peering into the pharmaceutical “pipeline”: Investigational drugs, clinical trials, and industry priorities

“…On the rise, however, were clinical trials for drugs related to addiction, which experienced a 200% increase in the same time period. Pharmaceuticalization scholarship should account for this rapidly developing area of industry R&D, especially given that this trend appears to be a renewed interest in old drugs (Campbell & Lovell, 2012). …”

Agonist Medications for the Treatment of Cocaine Use Disorder

“…In the case of buprenorphine-based therapies, the sponsor of the drug developed and tested dosage forms specifically designed for treatment of opioid use disorders. The sponsor demonstrated remarkable commitment of human and fiscal resources over B25 years, often working as a virtual partner with NIDA, to evaluate, develop, and garner FDA approval for these formulations, with no assurance that the product would be commercially successful (Campbell and Lovell, 2012). The many studies supported by the sponsor and NIDA included 'three adequate and well-controlled studies,' and many additional studies that unequivocally demonstrated efficacy, a favorable benefit-risk assessment, and the sponsor's commitment to a costly and extensive risk-management program as described in the NDA (FDA, 2002).…”

“…The many studies supported by the sponsor and NIDA included 'three adequate and well-controlled studies,' and many additional studies that unequivocally demonstrated efficacy, a favorable benefit-risk assessment, and the sponsor's commitment to a costly and extensive risk-management program as described in the NDA (FDA, 2002). In addition, it took the support of the White House Office of National Drug Control Policy, along with support by NIDA and the Substance Abuse and Mental Health Services Administration (SAMSH-SA), cooperation with the FDA, and 'Acts of Congress' to create a path for approval and potential office-based use of the product in 2002, and in ensuing years to gradually widen its access via willing treatment providers (Campbell and Lovell, 2012;FDA, 2002).…”

Leptin status alters buprenorphine-induced antinociception in obese mice with dysfunctional leptin receptors

“…Buprenorphine is a mu opiate receptor agonist and kappa opiate receptor antagonist used for pain management [6] and for treating opiate use disorder [13, 14]. Most data regarding buprenorphine have been derived from studies of normal weight males.…”