Ensysce Biosciences completes End of Phase 2 meeting with FDA on PF614

Ensysce Biosciences announced the completion of a constructive End of Phase 2 meeting with the Food and Drug Administration regarding its lead ‘Next Generation’ analgesic, PF614. The meeting facilitated an affirmation of the Company’s non-clinical program and enabled an exchange of constructive ideas regarding Ensysce’s Phase 3 clinical trial designs for PF614. As previously announced, the Company has performed five clinical studies to evaluate the safety, abuse potential and efficacy of PF614 for the treatment of severe pain. The clinical data has demonstrated that PF614 was bioequivalent to OxyContin for delivering oxycodone, meaning one could easily substitute PF614 for OxyContin in patients with pain. However, PF614 was found to have a longer half-life than OxyContin. Ensysce believes that the longer twelve-hour half-life could improve the pain-relieving qualities of PF614, reduce opioid-related adverse events, and provide true twice daily dosing. Evaluation of both nasal and oral abuse-potential studies met key endpoints that showed PF614 had significantly lower scores for “Overall Drug Liking” and willingness to “Take Drug Again” than the oxycodone comparator. Additionally, PF614 showed significant analgesic activity in a recent study that measured the time-of-onset of pain-relief in healthy volunteers. The study confirmed the prior clinical pharmacokinetic studies that measured oxycodone blood levels following oral administration of PF614 and showed that Ensysce’s TAAP chemical approach delivers strong analgesia. This study was key to the design of the Company’s Phase 3 clinical protocols and positive discussions with the FDA.