SAN DIEGO - Ensysce Biosciences Inc. (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage pharmaceutical company, has announced the publication of a study in the journal Clinical and Translational Science, which highlights the potential benefits of its drug candidate PF614. The study, titled "Clinical evaluation of PF614, a novel TAAP™ prodrug of oxycodone, versus OxyContin®," showed that PF614 has a longer half-life and maintains similar oxycodone exposure in both fasted and fed states compared to OxyContin.
PF614 is a Trypsin-Activated Abuse Protection (TAAP™) oxycodone prodrug designed to reduce the likelihood of recreational drug abuse. The clinical trial compared PF614 to OxyContin® in healthy volunteers to evaluate the safety and pharmacokinetics (PK) profile of PF614. The study consisted of two parts: a multi-ascending dose study and a bioequivalence arm. The latter demonstrated that 100 mg of PF614 provided equivalent plasma oxycodone levels to 40 mg of OxyContin, whether taken with or without food.
The extended half-life of PF614, which was observed to be 12 hours, could offer a significant advantage for patients by providing sustained analgesia and potentially reducing the need for additional medication for breakthrough pain.
Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences, expressed confidence in the drug's profile, stating that the study confirmed previous findings and highlighted the unique qualities of PF614, such as its fed/fasted equivalency and extended half-life. The company aims to introduce what it refers to as the 'next generation' of analgesics for severe pain treatment to the market.
Ensysce Biosciences specializes in developing safer prescription drugs using its proprietary TAAP™ and Multi-Pill Abuse Resistance (MPAR®) technology platforms. These platforms are intended to create tamper-proof treatment options that minimize the risk of drug abuse and overdose.
The company's progress is based on the assumption that its clinical programs will successfully demonstrate safety and efficacy, which is yet to be confirmed as PF614 continues through the clinical development process.
This report is based on a press release statement from Ensysce Biosciences.
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