Discovery and Development of Pregabalin (Lyrica): The Role of Public Funding

Background:Pregabalin (Lyrica), a widely used drug that has generated billions in revenue as a treatment for diabetic neuropathy and other conditions, was originally discovered in an academic medical center, largely supported by public funding.Objective:To define the extent of direct federal public funding that contributed to various stages of pregabalin’s development prior to Food and Drug Administration (FDA) approval.Methods:We identified key research, scientists and organizations involved in the development of pregabalin from its discovery through FDA approval. Using key terms (e.g., its indications and mechanism of action), we searched PubMed for relevant publications and determined whether each publication was based on federal public funding, using the National Institutes of Health RePORTER. For each award prior to the drug’s FDA approval, we scored its potential relatedness to pregabalin’s development based on its title, investigator, and organization, and then examined descriptions of the most relevant awards to aid in defining these relationships. The budgets for all related awards were converted to 2020 dollars.Results:Pregabalin was discovered largely on the basis of publicly funded research at Northwestern University; in 1990, it was licensed to Parke-Davis which further developed it through its FDA approval in 2004. Most key terms were related to the drug and drug-target (n=5) and organizations involved (n=5), followed by patent-listed inventors (n=3). These key terms linked 6,438 core project awards, and we identified 37 NIH awards related to pregabalin’s development: 9 awards through 1990 ($3.3 million) and 28 from 1991-2004 ($10.5 million).Conclusions:Like many other widely-sold medications, the development of pregabalin relied on public-sector as well as industry contributions to its discovery, with relevant NIH awards totaling $13.8 million during its pre-approval development.