Preclinical target validation for non-addictive therapeutics development for pain.

Area of Science:

• Pharmacology and Therapeutics
• Pain Management
• Drug Development

Background:

• The Helping to End Addiction Long-term Initiative aims to accelerate non-opioid pain therapeutic development.
• Clinical validation of novel pain targets is complex, costly, and rarely successful.
• De-risking therapeutic targets in preclinical stages is crucial for private sector investment.

Purpose of the Study:

• To outline a roadmap for validating non-addictive pain therapeutic targets.
• To gather insights from key opinion leaders in academia, industry, and venture capital.
• To enhance the efficiency and success rate of pain target validation.

Main Methods:

• A workshop was convened by the National Institutes of Health (NIH) in 2020.
• Key opinion leaders provided insights on target validation strategies.
• A roadmap was developed focusing on three core modalities.

Main Results:

• The roadmap emphasizes three key modalities for pain target validation: human evidence, in vitro assay development, and in vivo assay development.
• This structured approach aims to increase confidence in therapeutic targets.
• The initiative seeks to streamline the development of non-addictive pain therapeutics.

Conclusions:

• Rigorous preclinical validation is essential for advancing non-addictive pain therapeutics.
• The developed roadmap provides a framework for de-risking targets.
• Successful target validation will encourage private sector investment in clinical trials, ultimately aiding addiction treatment efforts.