An ad hoc committee will plan and conduct a 1.5-day public workshop that will bring together key stakeholders from government, academia, industry, and disease-focused organizations to discuss the development of drugs to treat opioid overdoses and to explore non-opioid alternatives for pain. The purpose of this workshop is to 1) advance the discussions that emerge from the three National Institutes of Health meetings scheduled in June and July 2017 to address the opioid epidemic and, 2) to examine potential implementation barriers and opportunities related to the proposed approaches discussed.

Invited presentations and discussions will be designed to:

• Review the state of the science for opioid and non-addictive pain treatments.
  • Provide an overview of emerging pain models, including those in the peripheral nervous system (e.g., induced pluripotent stem cells and human experimental biology).
  • Discuss the progress on the identification and validation of targets and biomarkers (neuroinflammation, genetic, proteomics, etc.). Explore whether there is a systematic methodology to validating biomarkers to determine their usefulness.
  • Examine approaches to testing new formulations and drugs, and discuss the patient populations needed for those clinical trials.
  • Consider the formulation of promising pain medications, beyond opioid analgesics, that may have been shelved by companies.
• Explore opportunities and challenges to changing the formulation of marketed prescription opioids to decrease misuse, addiction, and potential overdoses (e.g., different delivery systems and anti-tampering mechanisms).

• Consider regulatory issues related to the approval of pain medications and discuss potential opportunities to address those challenges.

• Discuss public-private partnerships that might facilitate and de-risk the development of drugs to treat overdoses and non-opioid therapeutics for pain (e.g., an Accelerating Medicines Partnership [AMP] for pain). Highlight lessons learned from industry and opportunities to advance the development of these drugs (e.g., a designated clinical trial network for pain).

The committee will develop the agenda for the workshop, select and invite speakers and discussants, and moderate the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.