Ensysce Biosciences Launches Phase 3 Trial For Abuse-Resistant Painkiller PF614, Selects Rho, Inc. As Clinical Partner

Author: Benzinga Newsdesk | July 16, 2025 08:05am

~ FDA Protocol Review Completed ~

~ Rho, Inc. Selected as Clinical Research Partner ~

SAN DIEGO, CA / ACCESS Newswire / July 16, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering novel solutions for severe pain with built-in abuse and overdose protection, today announced the initiation of its pivotal Phase 3 study of PF614, the Company's lead product candidate.

This landmark study, PF614-301, ‘A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty' is designed to demonstrate PF614's ability to effectively manage post-surgical pain while protecting from abuse and offering patients what is believed to be a safer alternative to conventional opioids. The study aims to confirm that PF614 delivers powerful pain relief and facilitates the transition to non-opioid out-patient care.

To execute this critical program, Ensysce has partnered with Rho, Inc., a leading Clinical Research Organization with extensive expertise in central nervous system (CNS) disorders and pain studies. Over the past five years, Rho has successfully managed more than 90 neurology and psychiatry trials at over 840 sites, guiding programs from first-in-human trials to regulatory approval - making them an ideal partner for Ensysce's transformative mission.

Posted In: ENSC