Integrated Strategies for Achieving Regulatory Milestones Faster: An Extended Release Case Study With Ensysce Biosciences

A sponsor was developing a novel opioid combination product for the potential treatment of moderate to severe pain designed to prevent both abuse and overdose. Pre-clinical data of immediate-release (IR) nafamostat demonstrated protection from overdose in animal models, but initial clinical data showed that IR nafamostat may not be sufficient in humans. To determine if an extended-release (ER) formulation might be required, three different variables would need to be evaluated clinically: ER release rate, ER/IR ratio, and the nafamostat dose level.

Quotient Sciences’ Translational Pharmaceutics platform integrates formulation development, real-time adaptive GMP manufacturing, and clinical testing to accelerate drug development and can be applied to enable drug product optimization in real-time based on arising clinical data using rapid ‘make-test’ cycles. Learn how the Translational Pharmaceutics platform reduced development timelines and allowed the sponsor to find the optimal nafamostat formulation without adding unnecessary delays.