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Ensysce Biosciences Announces Positive Bioequivalence (BE) Study Data of Novel "TAAP" Opioid PF614 and Provides Timing of Corporate Update Call
~ BE Study of PF614 Represents Critical Progress Toward FDA Approval ~~ Supports the 505(b)(2) Regulatory Path for Clinical Development of PF614 ~SAN DIEGO,
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ BE Study of PF614 Represents Critical Progress Toward FDA Approval ~~ Supports the 505(b)(2) Regulatory Path for Clinical Development of PF614 ~SAN DIEGO, CA / ACCESSWIRE / July 27, 2022 / Ensysce Biosciences, Inc. (\"Ensysce\" or the \"Company\") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, announced today the data from the Part B, Bioequivalence (BE) arm of the PF614-102 study examining the Company's 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 compared the release of oxycodone from PF614 versus OxyContin® administered to subjects in both fasted and fed states. This data is critical to understand future prescribing criteria for PF614 as an agent bioequivalent to OxyContin and therefore may be developed through the 505(b)(2) regulatory path as defined by the FDA.Dr. Nily Osman, Chief Medical Officer of Ensysce, commented, \"We continue to be highly encouraged by our progress towards bringing to market this important therapeutic option for pain management, especially the finding that the fed or fasting state has little effect on oxycodone absorption from PF614 in contrast to other commercial products. This may prove important for those ill patients lacking appetite when requiring pain medication. The completion of this study is a critical milestone for Ensysce and we believe a major step toward providing physicians a safer option to alleviate the suffering of patients.\"Commenting on the Company's progress, Dr. Lynn Kirkpatrick, CEO of Ensysce, stated, \"We have made strong advances across our clinical development of PF614 and are extremely pleased with the positive data from this BE study as we believe it positions PF614 to be a safer alternative to OxyContin. We are building the foundation of clinical data to support PF614 in a New Drug Application to realize our mission of bringing a unique pipeline of safer products onto the market and helping the millions who experience severe pain.\"In the BE study arm conducted in healthy volunteers (n=57), pharmacokinetics of oxycodone released from PF614 100 mg capsule was determined when taken with high-fat high-calorie (HFHC) meal, as well as i...