Abstract
Pain medication plays an important role in the treatment of acute and chronic pain conditions, but some drugs, opioids in particular, have been overprescribed or prescribed without adequate safeguards, leading to an alarming rise in medication-related overdose deaths. The NIH Helping to End Addiction Long-term (HEAL) Initiative is a trans-agency effort to provide scientific solutions to stem the opioid crisis. One component of the initiative is to support biomarker discovery and rigorous validation in collaboration with industry leaders to accelerate high-quality clinical research into neurotherapeutics and pain. The use of objective biomarkers and clinical trial end points throughout the drug discovery and development process is crucial to help define pathophysiological subsets of pain, evaluate target engagement of new drugs and predict the analgesic efficacy of new drugs. In 2018, the NIH-led Discovery and Validation of Biomarkers to Develop Non-Addictive Therapeutics for Pain workshop convened scientific leaders from academia, industry, government and patient advocacy groups to discuss progress, challenges, gaps and ideas to facilitate the development of biomarkers and end points for pain. The outcomes of this workshop are outlined in this Consensus Statement.
Highlights
Chronic pain, defined as pain that occurs on ≥50% of days over a period of at least 6 months or as pain that persists for at least 3 months[1], represents one of the most prevalent, costly and disabling health conditions[2]
To help improve pain management, there is a need to develop translational tools, such as well-validated biomarkers and objective clinical trial end points for pain, which could be used to select participants for clinical trials, demonstrate target engagement of new therapeutics and predict the therapeutic response. This topic provided the basis for the NIH Discovery and Validation of Biomarkers to Develop NonAddictive Therapeutics for Pain workshop. In this Con sensus Statement, we report on the outcomes of this workshop and provide guidance for the development and validation of biomarkers and end points for chronic pain
Three new drugs that utilize a non-opioid mechanism of action were recently approved by the Food and Drug Administration (FDA) for the treatment of migraine[12], but a large gap still remains in the available armamentarium to treat other types of chronic pain effectively
Summary
Target engagement A demonstration that the drug in question reaches its target in the body and, in doing so, results in a measurable effect (for example, opioid binding to the μ receptor). To help improve pain management, there is a need to develop translational tools, such as well-validated biomarkers and objective clinical trial end points for pain, which could be used to select participants for clinical trials, demonstrate target engagement of new therapeutics and predict the therapeutic response. This topic provided the basis for the NIH Discovery and Validation of Biomarkers to Develop NonAddictive Therapeutics for Pain workshop. In this Con sensus Statement, we report on the outcomes of this workshop and provide guidance for the development and validation of biomarkers and end points for chronic pain
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