Ensysce Biosciences announces publication of clinical bioequivalence manuscript

Ensysce Biosciences announced online publication of its manuscript entitled, “Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi-ascending dose study with a bioequivalence arm in healthy volunteers” published online by the open-access medical journal Clinical and Translational Science sponsored by the American Society of Clinical Pharmacology and Therapeutics. The article is authored by members of the Ensysce team plus external experts; D. Lynn Kirkpatrick PhD, Cari Evans RN, Linda A. Pestano PhD, Jeffrey Millard PhD, Matthew Johnston MD, Emily Mick PharmD, and William K. Schmidt PhD. The results from the two-part PF614-102 study are very significant as we believe they demonstrate a clear dose relationship between PF614 and oxycodone, which is the foundation for the FDA submission. The BE arm showed that plasma oxycodone bioequivalence was successfully achieved between 100 mg PF614 and 40 mg OxyContin. PF614 provided similar oxycodone exposures in both fasted and fed states, showing that it can be taken either on an empty stomach or with food, these data highlight PF614’s potential advantage compared to other marketed abuse deterrent formulation opioids. PF614 also showed a longer half-life, a major patient benefit in severe pain treatment. This manuscript provides a report of the safety and pharmacokinetics profile of PF614, a Trypsin-Activated Abuse Protection oxycodone prodrug designed to reduce recreational drug abuse. PF614 was compared to OxyContin in healthy subjects in the initial multi-ascending dose arm of the study. Additionally, the manuscript details the second arm which evaluated oxycodone release from PF614 and OxyContin administered to 60 subjects in both a fasted and fed state in order to assess whether PF614 is bioequivalent to OxyContin. The notable distinction identified in this study between PF614 and OxyContin was the longer half-life of PF614, which provides a benefit to the patient as this is a true twice daily pain treatment. We believe this differentiating feature is critically important as steady blood levels can deliver sustained analgesia throughout the day to prevent breakthrough pain and the need for additional therapeutics.