Overview of the Current Regulatory Landscape and Challenges in the Development of New Safer and Effective Analgesic Drugs

Panel Session

CHAIR: Judy Ashworth, MD, Senior Vice President, Pinney Associates
Panelists:
Ryan Lanier, Director, Clinical Development & Abuse Liability, Pinney Associates
Marc Lesnick, Ph.D., Chief Development Officer, Tris Pharma
Jeff Reich, MD, Co-founder & CEO, Sparian Biosciences

There is a high unmet medical need to develop new effective analgesics that offer safety advantages over currently available pain relievers such as opioids, which carry a high risk of abuse, overdose, and addiction. Recent efforts to develop new drugs with novel mechanisms of action have so far proven futile, whether due to insufficient evidence of effectiveness or the emergence of significant safety concerns. Efforts by industry to develop new analgesics have diminished in recent years for many reasons related to the numerous challenges associated with developing medications within this class. Recent changes in the regulatory landscape and public health initiatives intended to steer drug development efforts may provide some support and guidance to companies but may also introduce confusion or stifle development. This panel session will provide:

(1) An update on recent regulatory actions and public health efforts to promote the development of new, safer analgesics, such as the publication of new FDA draft guidances on analgesic drug development and public health initiatives such as the National Institutes of Health Helping to End Addiction Long-term® Initiative (NIH HEAL).

(2) An overview of the perspectives and challenges that companies now face when developing novel analgesics that range from obstacles to obtaining adequate financing, to demonstrating effectiveness via positive clinical trials, to navigating regulatory hurdles including, but not limited to, adequately assessing abuse potential and allowing for appropriate label differentiation from existing drugs.

17th Annual Pain Therapeutics

Friday, October 20, 2023  –  9:30 AM