Ensysce Biosciences Receives Investigational New Drug Allowance for its Unique PF614-MPAR™ Opioid with Overdose Protection
NEW YORK and SAN DIEGO, April 29, 2021 (GLOBE NEWSWIRE) -- Ensysce Biosciences, Inc. (“Ensysce”) and Leisure Acquisition Corp. (“LACQ”) (NASDAQ: LACQ, LACQU, LACQW), a special purpose acquisition company formed for the purpose of effecting a merger, acquisition or similar business combination, announced today that Ensysce has received U.S. Food and Drug Administration (“FDA”) allowance for an Investigational New Drug (IND) application for PF614-MPAR™, a two-step extended-release oxycodone prodrug which is designed to provide abuse deterrent and overdose protection properties.
PF614-MPAR™ is designed as an extended-release oxycodone prodrug with both trypsin-activated abuse protection (TAAP) and overdose protection through multi-pill abuse resistance (MPAR™). TAAP chemical modification inactivates the active ingredient in PF614 and provides abuse deterrence, and the combination with the trypsin inhibitor, nafamostat, in MPAR™ is designed to provide the additional layer of overdose protection. The MPAR™ overdose protection technology has been demonstrated in animals and the Phase 1 study with PF614 is being conducted to further validate the MPAR™ overdose protection technology. Ensysce believes its TAAP prodrugs and MPAR products are differentiated from current marketed opioid technologies due to their ability to reduce the potential for abuse as well as overdose and, therefore, make the products safer to keep in the medicine cabinet.
The trial, “A 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” is being conducted by Dr. Maricer Escalon MD, MS, MBA at Quotient Sciences - Miami, Inc.
“Ensysce is pleased to bring PF614-MPAR™ into clinical development with the financial support of the National Institute on Drug Abuse,” said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences. “Importantly, our proprietary prodrug approach is highly differentiated from currently marketed opioid products and designed to significantly reduce abuse potential and overdose protection. We remain focused on our commitment to stem the prescription drug abuse epidemic and look forward to bringing our unique pipeline of products to the industry, which will ultimately provide safer options for both prescribers and patients.”
As previously announced, on February 1, 2021, Ensysce entered into a definitive agreement for a business combination with LACQ, which would result in Ensysce becoming a publicly listed company. Upon closing of the transaction, LACQ intends to change its name to Ensysce Biosciences, Inc. and remain on the Nasdaq Capital Market, listed under the new ticker symbol “ENSC”.
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SOURCE Leisure Acquisition Corp.; Ensysce Biosciences, Inc.
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