Articles & Publications , Translational Pharmaceutics , Formulation Development , Clinical Pharmacology

Formulation Development and a Phase 1 Clinical Study of PF614-MPAR, an Oxycodone Prodrug with Oral Opioid Overdose Protection

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  • Formulation Development and a Phase 1 Clinical Study of PF614-MPAR, an Oxycodone Prodrug with Oral Opioid Overdose Protection
Overview

Prevention of oral overdose of opioids is a critical unmet need. Quotient Sciences worked with Ensysce Bio on a novel treatment and Phase 1 study to evaluate the company's PF614 product.

PF614-Multi-Pill Abuse Resistance (MPAR®) was designed to deliver desired opi-oid-level analgesia at therapeutic dose levels while providing overdose protection if consumed at higher-than-intended doses, through a unique trypsin-activated prodrug approach.

PF614, a prodrug of oxycodone, releases oxycodone only after oral ingestion and exposure to trypsin in the small intestine. PF614-MPAR, a com-bination of PF614 and a potent trypsin inhibitor, nafamostat, will reduce oxyco-done release if taken at higher-than-intended doses. The goal of this Phase 1 study was to determine the optimal PF614-nafamostat formulation to optimize the overdose protection that PF614-MPAR should provide.

Learn more about this study, with contributions from Dr. Vanessa Zann, Vice President of Scientific Consulting, Translational Pharmaceutics®- Clinical Pharmacology USA, and Katie Pepper, Senior Project Scientist.

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