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Ensysce Biosciences Announces IRB Approval of Key Study Protocol
~ Approval of Study Represents Progression Toward Full Phase 3 Evaluation of PF614 ~~ Study to Assess PF614 Time of Onset for Severe Pain Relief ~SAN DIEGO,
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ Approval of Study Represents Progression Toward Full Phase 3 Evaluation of PF614 ~~ Study to Assess PF614 Time of Onset for Severe Pain Relief ~SAN DIEGO, CA / ACCESSWIRE / August 8, 2023 / Ensysce Biosciences, Inc. (\"Ensysce\" or the \"Company\") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced the Investigational Review Board (\"IRB\") approval of PF614-201 protocol, ‘A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects.'The study will be conducted at Dr. Vince Clinical Research (DVCR) in Overland Park, Kansas, and is designed to confirm time of onset for pain relief by PF614.Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, \"The approval of this study protocol represents yet another key milestone that brings us one step closer to our full Phase 3 evaluation of PF614. PF614 is a chemically modified opioid product that requires initial metabolic transformation by trypsin in the small intestine for activation to be able to relieve severe pain in patients who require an opioid-level analgesic. Over the last year, we have been able to rapidly progress the clinical development of PF614 by establishing its bioequivalence to OxyContin and by showing it has limited desirability for use by recreational drug users, both of which we believe will lead to favorable labeling claims. This new study will be critical for understanding the optimal prescribing options for surgical patients. Additionally, we have been accumulating safety data for PF614 which will be important for our regulatory submissions in the future. We remain dedicated to bringing to market this new generation of pain products to alleviate the suffering of those who experience severe pain.\"Dr. Lynn Kirkpatrick, CEO of Ensysce offered, \"We believe that the features of PF614 are a game changer for the treatment of severe pain. We expect that the requirement for exposure to trypsin and the chemically designed release kinetics will separate PF614 from other marketed oxycodone drug products. Recently, we reported that PF614 is bioequivalent to OxyContin yet has a longer lasting half-life, consistent with true twice-daily dosing. These features, along with its reduced abuse potential, are intende...