NIH HEAL Initiative: National Institute of Neurological Disorders and Stroke Preclinical Program for Non-Addictive Pain Therapeutic Development

Abstract

Background: The NIH Helping to End Addiction Long-term (HEAL) Initiative aims to focus efforts on advancing scientific solutions to stem the opioid crisis, improving prevention and treatment of opioid misuse/addiction, and enhancing pain management. Goal: NINDS is charged with accelerating the discovery and development of new non-addictive pharmacologic and non-pharmacologic pain therapeutics as part of the HEAL Initiative. NINDS established the Preclinical Screening Platform for Pain (PSPP) to accelerate and enhance testing of novel, non-addictive pain therapeutics. This program will evaluate new, as well as repurposed, small molecules, biologics, devices, and natural products across a range of pain conditions. PSPP is accepting assets from academic and industry sponsors, worldwide. Here we describe efforts within the PSPP program. The overall goal of the PSPP program is to provide an efficient, rigorous, one-stop in vivo screening resource to accelerate identification and efficacy profiling of non-opioid therapeutics for the treatment of pain. Under NINDS direction, preclinical testing of submitted agents is performed by contract facilities on a blinded and confidential basis at no cost to the PSPP participants. Test candidates are evaluated in a suite of in vivo pain-related endpoints and models, following in vitro receptor profiling, pharmacokinetic and safety assessment. Importantly, test candidates are also evaluated in models of abuse liability. We will describe the advances made to date towards establishing program goals of evaluating assets in a rigorous and reproducible manner. Background: The NIH Helping to End Addiction Long-term (HEAL) Initiative aims to focus efforts on advancing scientific solutions to stem the opioid crisis, improving prevention and treatment of opioid misuse/addiction, and enhancing pain management. Goal: NINDS is charged with accelerating the discovery and development of new non-addictive pharmacologic and non-pharmacologic pain therapeutics as part of the HEAL Initiative. NINDS established the Preclinical Screening Platform for Pain (PSPP) to accelerate and enhance testing of novel, non-addictive pain therapeutics. This program will evaluate new, as well as repurposed, small molecules, biologics, devices, and natural products across a range of pain conditions. PSPP is accepting assets from academic and industry sponsors, worldwide. Here we describe efforts within the PSPP program. The overall goal of the PSPP program is to provide an efficient, rigorous, one-stop in vivo screening resource to accelerate identification and efficacy profiling of non-opioid therapeutics for the treatment of pain. Under NINDS direction, preclinical testing of submitted agents is performed by contract facilities on a blinded and confidential basis at no cost to the PSPP participants. Test candidates are evaluated in a suite of in vivo pain-related endpoints and models, following in vitro receptor profiling, pharmacokinetic and safety assessment. Importantly, test candidates are also evaluated in models of abuse liability. We will describe the advances made to date towards establishing program goals of evaluating assets in a rigorous and reproducible manner.