Ensysce Biosciences (NASDAQ:ENSC) Phase 1 Data Validates Overdose-Limiting Opioid Technology

SAN DIEGO, CA — March 3, 2026 — Leads & Copy — A clinical manuscript describing Ensysce Biosciences’ MPAR® (Multi-Pill Abuse Resistance) overdose protection technology has been published in the Journal of Opioid Management.

The paper, titled “Formulation and a Phase 1 Clinical Study of PF614-MPAR, an Oxycodone Prodrug with Oral Opioid Overdose Protection,” appears online in the Jan/Feb 2026 issue of the Journal of Opioid Management.

The study validates the first phase 1 data of PF614-MPAR which is the first opioid candidate specifically designed to provide active protection against oral overdose-a limitation not addressed by currently marketed abuse-deterrent formulations.

According to Ensysce Biosciences, MPAR® technology is engineered to maintain therapeutic opioid exposure when taken as prescribed while automatically limiting additional opioid release when excessive numbers of pills are consumed.

Data presented in the publication demonstrate that PF614-MPAR achieved appropriate opioid plasma levels under normal dosing conditions, while preventing large increases in opioid delivery when supratherapeutic doses were administered. These findings support the potential for a fundamentally new safety paradigm in opioid analgesia.

MPAR® previously received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) in January 2024 based on this clinical evidence and the technology is protected by a growing intellectual property portfolio extending through 2042.

Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, said the peer-reviewed publication marks a defining milestone not only for Ensysce, but for the field of pain medicine. Dr. Kirkpatrick also noted that CDC data projects that almost 80,000 people die every year from opioid overdose of which prescription opioids factor into 12.4% of these deaths.

The clinical work reported in this publication allowed for the optimization of the MPAR® formulation and the confirmation that the overdose-limiting mechanism functions as intended in humans. The continued support from the National Institute on Drug Abuse helped enable this study and the ongoing second clinical trial evaluating the MPAR® technology.

Beyond opioid analgesics, Ensysce is advancing MPAR® across additional therapeutic categories-including amphetamines and methadone-with the goal of developing safer treatments for pain, attention-deficit/hyperactivity disorder (ADHD), and opioid use disorder.

Ensysce Biosciences is a clinical-stage company developing novel opioids for the treatment of severe pain. Leveraging its Trypsin-Activated Abuse Protection (TAAP™) 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.

Source: Ensysce Biosciences

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