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Ensysce Biosciences Announces First Cohort Dosing in Bioequivalence (BE) Study of Novel “TAAP” Opioid
BE Study of PF614 Provides Critical Step toward FDA Approval SAN DIEGO, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Ensysce Biosciences, Inc. (“Ensysce” or the
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"BE Study of PF614 Provides Critical Step toward FDA Approval\nSAN DIEGO, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Ensysce Biosciences, Inc. (“Ensysce” or the “Company”) (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company with two novel technology platforms designed to provide relief for those suffering with severe pain while protecting against abuse and overdose, announced today 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. Dr. William Schmidt, Chief Medical Officer of Ensysce, commented, “We continue to be encouraged by our progress towards bringing our lead ‘next generation’ opioid to market. The completion of this study will be a critical milestone for Ensysce and a major step toward providing safer options for doctors and patients.” Commenting on the Company’s progress, Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, stated, “As we enter 2022 with strong progress across our clinical stage pipeline, we are looking forward to the data from this BE study in the second quarter of the year to position PF614 as our first commercial candidate. We believe that we have the foundation in place to realize our mission of bringing a unique pipeline of products onto the market and helping the millions who experience severe pain.” 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 Phas...