~ Study Initiation Brings PF614 One Necessary Step Closer to Phase 3 ~
~ Trial Results Expected Before Year End 2023 ~
SAN DIEGO, CA / ACCESSWIRE / September 26, 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 Site Initiation Visit (SIV) was completed for the PF614-201 study, ‘A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects’ to evaluate time of onset for PF614. The study is being conducted by Dr. George Atiee at Dr. Vince Clinical Research (DVCR) in Overland, KS.
Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, “Each study serves a critical purpose and this new study’s importance is grounded in the ability to best determine optimal prescribing options for surgical patients, while also key in preparing for our full Phase 3 evaluation of PF614. We have determined PF614 has reduced abuse potential, has a longer lasting half-life than the current abuse deterrent products, yet is bioequivalent to OxyContin for pain relief, and we believe the features of PF614 will provide superior pain relief that may be needed following some types of surgery.”
Dr. Lynn Kirkpatrick, CEO of Ensysce, offered, “The completion of the SIV for this study represents yet another key milestone in our development path for 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. We believe PF614 will be a game changer for the treatment of severe pain and represents a new generation of pain products. We look forward to continuing our progress and conducting this trial with results expected in late 2023.”
