Ensysce Biosciences Reports Positive Opioid Overdose Protection Study Results

Ensysce Biosciences, Inc., a pharmaceutical company based in San Diego, has reached a significant milestone with the completion of Part 1 of its second clinical trial for PF614-MPAR. This trial aims to evaluate the effectiveness of PF614-MPAR in providing overdose protection while offering relief from severe pain. Ensysce’s innovative drug combines two proprietary technologies, TAAPTM and MPAR®, to achieve these objectives.

The first part of this clinical study focused on assessing the ability of a 100 mg dose of PF614-MPAR to deliver oxycodone for severe pain management while providing protection against overdoses, whether accidental or intentional. Participants in the study were given up to five doses of PF614-MPAR and their results were compared against an unprotected version, PF614. The findings demonstrated that the release of oxycodone from PF614-MPAR was significantly reduced when multiple doses were taken simultaneously, showcasing its overdose protection capabilities. Notably, the study found that administering five doses provided greater protection compared to three doses. Importantly, there were no unexpected adverse reactions reported for either PF614 or PF614-MPAR.

These findings are promising, especially when combined with data from the earlier PF614-MPAR-101 study. Ensysce plans to discuss this comprehensive analysis with the FDA to outline the full development strategy for PF614-MPAR. The continuation of the trial will involve examining potential food effects and evaluating the effects of repeated dosing in subsequent phases. The combined data will assist Ensysce in finalizing the drug for commercialization.

Dr. Bill Schmidt, Ensysce’s Chief Medical Officer, acknowledged the importance of these clinical results, emphasizing that MPAR® is crucial for reducing overdose risks associated with prescription medications. He highlighted that PF614-MPAR has received the FDA's Breakthrough Therapy designation, making it unique in the opioid market. Dr. Lynn Kirkpatrick, CEO of Ensysce, expressed optimism about the encouraging safety data that distinguishes PF614-MPAR from other opioids. The company is rapidly progressing through the final stages of the study with the assistance of Quotient Sciences and is preparing for commercial manufacturing. Dr. Kirkpatrick looks forward to working with the FDA to navigate the registration process for this novel opioid product.

The PF614-MPAR-102 clinical trial, officially titled “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 of Immediate Release Solution and Extended Release Capsule Formulations (PF614-MPAR) in Healthy Subjects,” is structured to explore the complete dosage spectrum of the drug, potential food interactions, and multiple ascending dose studies with the final PF614-MPAR formulation.

Ensysce Biosciences is committed to transforming the landscape of pain management by developing advanced opioid options that address severe pain while minimizing abuse and overdose risks. Through its TAAPTM and MPAR® platforms, the company is creating unique, tamper-resistant treatments that offer safer alternatives for patients, potentially reducing medication-related fatalities.