Ensysce Biosciences Advances Innovative Overdose Protection Platform

Ensysce Biosciences Inc., a clinical-stage pharmaceutical company focused on developing pioneering pain relief solutions while mitigating opioid abuse and overdose risks, has announced the renewal of its partnership with Quotient Sciences. The joint effort will spearhead the PF614-MPAR-102 study, which aims to assess and validate the entire commercial dosage spectrum of the PF614-MPAR drug product.

PF614-MPAR is a novel opioid product incorporating Multi-Pill Abuse Protection (MPAR) technology, which prevents opioid release if an excessive number of pills are consumed. This innovative approach can avert both intentional and accidental overdoses, presenting a significant advancement in opioid safety. The product has achieved Breakthrough Therapy designation from the U.S. Food & Drug Administration (FDA), underscoring its potential to make a substantial impact in the field.

The forthcoming Phase 1b study, PF614-MPAR-102, is designed to scrutinize the release of opioids after administering PF614-MPAR in doses of 25 mg, 50 mg, and 100 mg twice daily over a span of five days. This investigation will confirm both the overdose prevention capability and the effective delivery of oxycodone. The study will employ the Quotient Sciences Translational Pharmaceutics® platform, which is renowned for accelerating the clinical trial process through efficient manufacturing and testing of drug products.

Dr. Lynn Kirkpatrick, CEO of Ensysce, expressed enthusiasm about the ongoing collaboration with Quotient Sciences. She articulated the team's objective of offering prescribers and patients a safer, innovative option for managing severe pain, thereby addressing significant concerns of opioid overdose. She highlighted the urgency of this solution, particularly in the context of the ongoing prescription opioid overdose crisis in the United States, which has led to stringent regulatory measures and subsequent supply challenges for patients enduring severe pain. The potential advantages of the MPAR platform were emphasized by Dr. Rick Dart during the PAINWeek conference in 2023.

Breakthrough Therapy designation is a prestigious status, granted to a select few drugs since its inception in 2012, aiming to fast-track the development and review of drugs that show preliminary clinical evidence of substantial improvement over existing treatments for serious conditions.

Quotient Sciences is a global accelerator in drug development and manufacturing, collaborating with pharmaceutical and biotech companies worldwide. They provide integrated services encompassing contract research, development, and manufacturing. Their expertise was pivotal in developing the initial 25 mg dosage form of PF614-MPAR through their unique Translational Pharmaceutics® process.

Ensysce Biosciences leverages its proprietary technology platforms, Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®), to create prescription drugs that are resistant to tampering and abuse. These platforms are designed to offer safer pain treatment options, thereby reducing the risk of drug abuse and overdose. The company's products promise to provide safer alternatives for patients with severe pain and help prevent deaths caused by medication abuse. Ensysce's technological advancements are protected by a comprehensive global intellectual property portfolio covering a wide range of prescription drug compositions.