Executive Summary — Development of Safe, Effective, and Non-Addictive Pain Treatments

NIH Cutting Edge Science Meeting Series to End the Opioid Crisis

June 16, 2017

As part of a government-wide effort to address the opioid crisis, the National Institutes of Health (NIH) initiated a public-private collaborative research initiative on (1) new and innovative medications and biologics to treat opioid addiction and for overdose prevention and reversal; (2) safe, effective, and non-addictive strategies to manage chronic pain; and (3) neurobiology of chronic pain.

To identify the scientific strategies with the greatest potential for solutions to the opioid problem, NIH is bringing together innovative experts from government, industry, and academia for a series of three cutting-edge science meetings. NIH seeks to pursue new approaches and recruit additional expertise with the aim of developing new safe and effective therapeutics for opioid abuse and chronic pain in half the time it currently takes.

The first of these meetings was held on June 5th, entitled Medications Development for Opioid Use Disorders and Overdose Prevention and Reversal. The second meeting, entitled Development of Safe, Effective, and Non-Addictive Pain Treatments, was held on June 16thand is summarized below.

Key Themes

  • There has been significant progress in target identification and structure based drug development; there are many therapeutics in the pipeline.
  • There is a need to reset expectations of what is achievable with pain treatment. Complete relief may not be attainable for all patients. The goal of chronic pain treatment may be to reduce pain so that the patient can be aggressively rehabilitated, so the underlying causes of pain can be addressed.
  • Heterogeneity—in both underlying pathology and confounding factors—among patients with chronic pain poses significant challenges in clinical trials.
  • Objective biomarkers are needed to improve the speed and efficiency of clinical trials.
  • Better animal models with predictive validity are needed.
  • There is a need for more basic research on a diverse range of pain conditions.
  • Advances in neuroscience technologies are poised to accelerate the development of treatments targeted to the neurobiological substrates of pain.
  • There is significant potential value in coordinating across both pharmaceutical and academic research.
    • Significant overlap in the targets being pursued by different companies.
    • Common technical challenges that everyone is working on independently.
    • Coordination would allow for the more efficient use of limited resources.
  • Patient advocacy groups have a valuable perspective that should inform the research agenda.

Possible Next Steps

NIH aims develop an action plan by October 2017 to:

  1. Developing a data sharing cooperative
  2. Establishing a clinical trials network with cohorts of patients with severe unmet treatment needs.
  3. Initiating an effort to develop objective measures of pain (e.g. a “noci-ometer(s)” grand challenge).
  4. Accelerating development of therapeutics including:  disease modifying drugs, compounds in late stage development, repurposed compounds, and validation of current and new targets.