Ensysce Biosciences announces efficacy data for PF614

Ensysce Biosciences announced that its most recent study has demonstrated crucially important data for PF614 on pain intensity efficacy and speed of onset. 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’, which completed enrollment in November 2023, demonstrated time-to-efficacy onset for the analgesia effect and significant decrease of pain intensity versus placebo of PF614 at two different dose levels, the first ever measured for this TAAP opioid. The study endpoints matched all previous clinical studies, demonstrating that Ensysce’s TAAP chemical approach delivers strong analgesia safely and effectively. This ‘time of onset’ study data supports the key elements of our Phase 3 study designs that will allow the Company to affirm its Phase 3 plans and launch strategy for PF614 with the FDA during its End of Phase 2 meeting scheduled in late January 2024.