Business
Ensysce Biosciences Announces Data from PF614-MPAR-101-Part A Successfully Demonstrating Opioid Overdose Protection
~ PF614-MPAR will be the Industry's First Overdose Protection Pain Product ~SAN DIEGO, CA / ACCESSWIRE / December 19, 2022 / Ensysce Biosciences, Inc.
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ PF614-MPAR will be the Industry's First Overdose Protection Pain Product ~SAN DIEGO, CA / ACCESSWIRE / December 19, 2022 / Ensysce Biosciences, Inc. (\"Ensysce\" or the \"Company\") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, today announced data demonstrating the overdose protection of its drug product, PF614-MPAR from the clinical study being conducted in Healthy Subjects by Dr. Maria Bermudez MD, at Quotient Sciences, Miami, Florida.PF614-MPAR is designed to provide optimal pain relief at prescribed doses. Accidental or intentional overdose is limited by the overdose protection built into each capsule with the addition of Ensysce's formulated nafamostat ingredient. With MPAR technology, one or two PF614-MPAR capsules taken as prescribed will release the expected concentration of oxycodone required to provide pain relief as intended. However, when three or more capsules are taken, the increased exposure to nafamostat inhibits the trypsin-mediated release of oxycodone from the excess PF614 ingested, allowing the inactive parent drug to pass through the body unmodified. The recently completed Part A of the trial allowed the optimization of the nafamostat formulation by evaluating the PF614/nafamostat combination for both release rate and ratio of the combination. Data from the trial was able to show that in healthy subjects we could deliver oxycodone similarly with PF614 and PF614-MPAR, which was the goal of the study. Additionally, and as anticipated, the results of the study demonstrated that a large overdose of PF614-MPAR would result in diminished oxycodone release and uptake as compared to an equivalent amount of an unprotected opioid. In early 2023, the final formulation selected from this study will be evaluated as increasing dose units of PF614-MPAR in a group of healthy subjects in Part B of the study.Dr. Lynn Kirkpatrick, CEO of Ensysce, commented, \"PF614-MPAR is an opioid pain product designed to provide two layers of safety, one to reduce casual abuse and the second to prevent accidental overdose. We believe the data we present today demonstrates that our approach to limiting opioid release with our combination oxycodone product, PF614-MPAR, may save lives.\"Continued Dr Kirkpatrick, \"This uniqu...