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Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), 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 treated its first group of subjects in the PF614-MPAR-102 study. PF614-MPAR received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and had its development bolstered by the recent $14 million multi-year award from the National Institute on Drug Abuse (NIDA).
Dr. Lynn Kirkpatrick, CEO of Ensysce, was quoted, "Overdose from prescription drugs is still a major societal issue and Ensysce may have the first opioid that can reduce deliberate and accidental overdoses. My team has made this program a priority as we continue to collaborate with Quotient Sciences using their Translational Pharmaceutics® platform. We are delighted with the speed at which Quotient has executed the trial start-up activities and advanced into subject dosing as we aim to receive early interim data in the first quarter of 2025. We look forward to completing this highly important three-part trial and generating additional evidence to conduct productive discussions with the FDA on the path to registration for the first overdose-protected opioid."
Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, "Clinical data from our initial study demonstrated the unique overdose protection built into PF614-MPAR, which led to the FDA designation of Breakthrough Therapy, a first for an opioid drug product. We believe this second study will further build on our initial data and aid in bringing PF614-MPAR and a new generation of safer analgesics to the market to alleviate suffering and bring relief to those who experience severe pain."
The trial ‘A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is Co‑Administered with Nafamostat as a combination Immediate Release solution and Extended-Release Capsule Formulation in Healthy Subjects', is designed to evaluate the full dosage range of PF614-MPAR, study food effects and to conduct a multi-ascending dose study.
About Ensysce Biosciences
Ensysce Biosciences is a clinical stage company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAPTM) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com.