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Ensysce Biosciences Announces Completion of Enrollment for Groundbreaking Opioid Overdose Protection Study
~ Data Demonstrates Exceptional Safety Profile of PF614-MPAR, the Industry's First Overdose Protection Pain Product ~SAN DIEGO, CA / ACCESSWIRE / March 22,
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ Data Demonstrates Exceptional Safety Profile of PF614-MPAR, the Industry's First Overdose Protection Pain Product ~SAN DIEGO, CA / ACCESSWIRE / March 22, 2023 / Ensysce Biosciences, Inc. (\"Ensysce\" or the \"Company\") (NASDAQ:ENSC), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety, today announced the completion of enrollment in the final stage of the Phase 1 study, PF614-MPAR-101. This study was conducted by Dr. Maria Bermudez MD, at Quotient Sciences, Miami, Florida.PF614-MPAR is the overdose protectionderivative of the Ensysce lead product PF614 and holds the promise of protecting against multiple forms of abuse and overdose, an industry first. The added layer of overdose protection is made possible by combining PF614 with a trypsin inhibitor, nafamostat, to prevent overdose if too many pills are swallowed.The combination product, PF614-MPAR, is designed to provide optimal pain relief at prescribed doses yet limit accidental or intentional overdose by ‘shutting down' opioid release if too much active drug is consumed. This product, if approved, could herald a new class of treatment for the most severe forms of pain, with built-in protection in each capsule against the issues which plague traditional opioids.Overdose deaths in the US remain out of control, with the latest figures from the National Institute on Drug Abuse showing over 106,000 deaths in 2021, averaging over 250 deaths per day. Safer opioids to treat severe pain while providing protection against abuse and overdose are vital to reverse this tragic trend. Prescription opioid overdose deaths result when patients ingest too many pills accidentally, and often when younger people get unintended access to the prescription products.The first stage of the study, reported previously, manufactured and tested a number of nafamostat formulations allowing determination of the final PF614 and nafamostat combination composition. The results for both safety and pharmacokinetics demonstrated that MPAR overdose protection may be achieved with the selected nafamostat formulation.This last stage of the trial was conducted to confirm that the selected PF614/nafamostat composition would allow oxycodone release and hence pain relief at the prescribed dose of one to two capsules yet would reduce oxycodone release if three or more...