Preclinical Screening Platform for Pain
The Research Need
The overreliance on prescription opioids for the management of chronic pain conditions, despite limited effectiveness among some patients, has contributed to the recent epidemic of deaths due to opioid overdose. In order to facilitate the identification and development of urgently needed effective and non-addictive pain therapeutics, rigorous preclinical screening and abuse liability testing, and in vivo efficacy profiling are required in models that are relevant to human patients with acute and chronic pain conditions.
About the Program
Within the NIH HEAL Initiative, the National Institute of Neurological Disorders and Stroke (NINDS) created the Preclinical Screening Platform for Pain to (PSPP) identify and profile non-addictive therapeutics (small molecules, biologics, devices, or natural products) for acute and chronic pain.
The PSPP is an efficient, rigorous, one-stop screening resource to accelerate discovery of effective, non-addictive pain therapies. The program offers testing, including an assessment of in vitro and pharmacokinetic profiles, side effect profiles, abuse liability, and efficacy in models relevant to human pain conditions.
An External Consultant Board provides independent input and guidance on scientific and strategic priorities and implementation, including input on selecting new models, developing and monitoring screening flows, prioritizing targets and mechanisms for interrogation, and establishing milestones for program progress.
To date, through the NIH HEAL Initiative, NIH has awarded $43.4 million to fund this program.
Evaluation of a submitted compound for suitability for testing in the PSPP begins with an assessment of the proposed scientific rationale. Accepted agents are evaluated in assays whose sequence is described in specific flow charts. NINDS PSPP staff consult with participants at each stage of evaluation. The PSPP provides participants with feedback on results and recommends next steps in the process.
How to Participate
The PSPP is accepting compounds for evaluation continuously. Researchers from academia and industry in the United States or abroad are eligible to submit compounds for screening. A signed confidentiality agreement between NINDS and each potential participant is required before the potential participant submits compounds for evaluation.
To start the process, those interested in participating should contact Smriti Iyengar, Ph.D., for more information and to discuss research goals, resources and timelines. For compounds approved for testing in the program, initial evaluation is normally performed using in vitro assays and rat pharmacokinetic studies. The amount of compound required for subsequent testing in pain models will vary depending on the expected dose range. The program will provide directions for packaging and compound submission before sample shipment.
NIH recognizes the importance of confidentiality to the success of the PSPP and its participants. Participation in the PSPP begins only after the appropriate representatives from both the participant's organization and NINDS sign the participant agreement. This document defines the legal parameters for the partnership. All screening and other communication activities are performed in strict confidence to allow participants to retain IP. Chemical structures are considered proprietary unless otherwise specified by the supplier. The only testing undertaken by the PSPP is that agreed upon by participants in collaboration with PSPP personnel. To further ensure confidentiality, the PSPP assigns each newly submitted compound a unique number code to be used in communications, tracking, and analysis. Screening personnel are blinded to both the structure and the source of submitted compounds, and the PSPP provides screening results exclusively to the participating supplier unless otherwise authorized.
Participating NIH Institutes, Centers, and Offices
- Fogarty International Center (FIC)
- National Cancer Institute (NCI)
- National Center for Advancing Translational Sciences (NCATS)
- National Center for Complementary and Integrative Health (NCCIH)
- National Eye Institute (NEI)
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institute on Aging (NIA)
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- National Institute of Biomedical Imaging and Bioengineering (NIBIB)
- National Institute of Dental and Craniofacial Research (NIDCR)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institute on Drug Abuse (NIDA)
- National Institute of Neurological Disorders and Stroke (NINDS)