Ensysce Biosciences Announces IRB Approval for Key MPAR Study
Summary
Next Clinical Trial of FDA Breakthrough Therapy PF614-MPAR Supported by $14 Million Federal Government GrantSAN DIEGO, CA / ACCESSWIRE / August 27, 2024 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced that it has received Investigational Review Board ("IRB") approval of the PF614-MPAR-102 protocol, A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is CoAdministered with Nafamostat as a combination Immediate Release solution and Extended-Release Capsule Formulation in Healthy Subjects. Bill Schmidt, Chief Medical Officer of Ensysce, commented, "The approval of this study protocol represents another key milestone towards completing the clinical development of our first-in-class opioid with both abuse and overdose protection. Ensysces products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. It is designed to expedite the development and review of drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies.Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law.