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Discovery and Development of Pregabalin (Lyrica): The Role of Public Funding
Neurology ( IF 7.7 ) Pub Date : 2021-10-26 , DOI: 10.1212/wnl.0000000000012730
Rachel Barenie 1 , Jonathan Darrow 1 , Jerry Avorn 1 , Aaron S Kesselheim 1
Affiliation  

Background and Objectives

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. We aimed to define the extent of direct federal public funding that contributed to various stages of pregabalin's development prior to US 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 NIH 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 through 2004 ($10.5 million).

Conclusion

Like that of 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 preapproval development.



中文翻译:

普瑞巴林 (Lyrica) 的发现和开发:公共资金的作用

背景和目标

普瑞巴林 (Lyrica) 是一种广泛使用的药物,作为治疗糖尿病神经病变和其他疾病的药物已产生数十亿美元的收入,最初是在学术医疗中心发现的,主要由公共资金支持。我们的目标是确定在美国食品和药物管理局 (FDA) 批准之前对普瑞巴林开发各个阶段做出贡献的直接联邦公共资金的范围。

方法

从普瑞巴林的发现到 FDA 的批准,我们确定了参与普瑞巴林开发的关键研究、科学家和组织。使用关键术语(例如,其适应症和作用机制),我们在 PubMed 中搜索相关出版物,并使用 NIH RePORTER 确定每个出版物是否基于联邦公共资金。对于药物获得 FDA 批准之前的每个奖项,我们根据其名称、研究者和组织对其与普瑞巴林开发的潜在相关性进行评分,然后检查最相关奖项的描述以帮助定义这些关系。所有相关奖项的预算均已转换为 2020 美元。

结果

普瑞巴林主要是在西北大学公共资助研究的基础上发现的。1990 年,它被授权给 Parke-Davis,并于 2004 年通过 FDA 的批准进一步发展。大多数关键术语与药物和药物靶点(n = 5)以及涉及的组织(n = 5)有关,其次是专利- 列出的发明人(n = 3)。这些关键术语将 6,438 个核心项目奖项联系起来,我们确定了 37 个与普瑞巴林开发相关的 NIH 奖项:1990 年的 9 个奖项(330 万美元)和 1991 年至 2004 年的 28 个奖项(1050 万美元)。

结论

与许多其他广泛销售的药物一样,普瑞巴林的开发依赖于公共部门和行业对其发现的贡献,在其预先批准开发期间,相关的 NIH 奖励总额为 1380 万美元。

更新日期:2021-10-26
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