Buprenorphine for opioid use disorder: The role of public funding in its development

Abstract

Background: Buprenorphine is a highly effective, office-based treatment for opioid use disorder (OUD), but affordable access to it remains challenging despite initial government investment in its development. We aimed to estimate the public sector's contribution to the development of buprenorphine for OUD.

Methods: We researched buprenorphine's timeline of development as an OUD treatment to identify key terms (e.g., authors of pivotal studies, labeled indication). We then conducted a PubMed search for each key term. We extracted article identification numbers and linked them to federal funding through the NIH RePORTER. We reviewed the title, investigator, and organization of each award distributed up to and including 2002 and classified awards as "highly related," "possibly related," or neither. Amounts of related awards were converted to 2019 US dollars.

Results: Over the course of nearly four decades, the active ingredient in buprenorphine was synthesized by a pharmaceutical manufacturer, but it was developed for OUD primarily by investigators in government and academic centers, including a formal government-industry partnership for commercialization. We identified 29 key terms related to its development as an OUD treatment that linked to 7060 NIH awards. Among these awards, 40 were "highly related" ($39.9 million) and 20 were "possibly related" ($22.4 million).

Conclusions: An estimated $62.3 million in NIH awards to institutions and investigators supported the development of buprenorphine as a treatment for OUD. Despite this investment by the public sector, buprenorphine remains expensive, which limits access to this important treatment.

Keywords: Buprenorphine; Drug development; Government funding; Opioid use disorder.