Results: A key component of the PSPP is to validate new and existing models and endpoints. All experiments are blinded, both sexes are included, group sizes are determined by power analysis, and data are reported in accordance with ARRIVE guidelines In vivo pharmacokinetic studies are then used to measure plasma and brain exposures to guide the dose range and pretreatment times for the side effect profile, in vivo efficacy, and in vivo abuse liability studies. Assets are evaluated in a tiered manner, starting with in vitro functional assays to rule out opioid receptor activity and to assess in vitro abuse liability. Methods: The PSPP aims to screen and profile candidate therapeutics in a number of preclinical assays. PSPP is working with PsychoGenics to develop and validate preclinical models and endpoints to enable the screening and profiling of assets, including small molecules, biologics, natural products, and devices. Toward this goal, NINDS created the Preclinical Screening Platform for Pain (PSPP) with the aim of accelerating the preclinical development of non-opioid, non-addictive therapeutics for pain. As part of the NIH HEAL Initiative, the National Institute of Neurological Disorders and Stroke (NINDS) has been charged with enhancing pain management and accelerating the discovery and development of new non-addictive pain therapeutics. Efforts to Develop and Validate Models and Endpoints Within the NINDS Preclinical Screening Platform for Pain (PSPP) Taleen Hanania, Mark Varney, Emer Leahy, David Budac, Elizabeth Dugan, Steven Leiser, Mark Urban, Sarah Woller, Smriti Iyengar* NINDS/NIH, Carmel, Indiana, United Statesīackground: The NIH Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, is a trans-agency effort to provide scientific solutions to the opioid crisis.
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