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Ensysce Biosciences Announces Completion of Clinical Portion of Overdose Protection Trial PF614-MPAR-101-Part A
~ Completion of Trial Represents Continuing Progress Towards Development of the Industry's First Overdose Protection Pain Product ~SAN DIEGO, CA / ACCESSWIRE
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ Completion of Trial Represents Continuing Progress Towards Development of the Industry's First Overdose Protection Pain Product ~SAN DIEGO, CA / ACCESSWIRE / December 5, 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 that it has successfully completed the clinical portion of study PF614-MPAR-101 Part A, entitled ‘Single-Dose Study to Evaluate the Pharmacokinetics of oxycodone and PF614, when PF614 Solution is Co-Administered with Nafamostat, as an Immediate-Release Solution and/or Extended-Release (ER) Capsule Formulations in Healthy Subjects', being conducted by Dr. Maria Bermudez MD, at Quotient Sciences, Miami Florida.Dr. Lynn Kirkpatrick, CEO of Ensysce, commented, \"Overdose with opioids is a societal crisis. Hundreds of Americans die each day due to deliberate and accidental overdoses. PF614-MPAR is designed to provide two layers of safety, one to reduce casual abuse and the second to prevent accidental overdose. We are looking forward to reporting the final data from this part of the trial and expect to do so by the end of this month.\"\"We believe the data from this trial will allow us to define the exact ratio of PF614 and nafamostat in PF614-MPAR that will be necessary to provide optimal pain relief with overdose protection. We are expanding the study in a Part B in 2023 in order to confirm the overdose protection with escalating dose units,\" continued Dr Kirkpatrick. \"It has been a pleasure partnering with Quotient Sciences, using their Translational Pharmaceutics platform to perform the clinical portion of this unique study with both abuse and overdose protection in the same medication to treat severe pain.\"MPARTM (Multi-Pill Abuse Resistance) is designed to prevent drug overdose by inhibiting the activation and release of opioid when more than prescribed doses are taken. PF614 is a TAAPTM (Trypsin Activated Abuse Protection) prodrug of oxycodone designed to reduce abuse of this opioid pain medication. TAAPTM chemical modification inactivates the active ingredient in Ensysce's products until they are swallowed and exposed to a digestive enzyme, trypsin. PF614 requires exposure to trypsin, which safely turns ‘on' the...