Ensysce Biosciences, Inc. announced the initiation and first dosing in the Bioequivalence (BE) trial of the novel Trypsin Activated Abuse Protected (TAAP) Opioid, PF614. The BE study follows the successful completion of the multi-ascending twice daily dosing study of PF614 and will compare PF614 versus OxyContin in subjects in both fasted and fed states. This data will be critical to understand future prescribing criteria for PF614.

If successful, upon completion of the BE study the Company believes that the data will support the 505(b)(2) regulatory path for clinical development of PF614, an abbreviated pathway to FDA approval. This pathway allows reference to available safety and clinical data from an approved product, and the BE data established by this study will move PF614 closer to registration. PF614 is designed as an abuse protective agent with trypsin-activated abuse protection (TAAP).

TAAP chemical modification inactivates the active ingredient in Ensysce's opioids products including PF614 and provides abuse protection, resistance to manipulation and other forms of recreational drug abuse. This study will build on the safety and pharmacokinetic results of the initial Phase 1 and 1b studies and is designed to improve the understanding of how PF614 compares to currently available commercial products.