Ensysce Biosciences announces database lock for HAP study of PF614

Ensysce Biosciences announced the database lock on February 24, 2023 for the oral Human Abuse Potential study of PF614. PF614 is a TAAP product to treat severe pain. With the database lock, no further change to the trial data is permissible such that all clinical trial data is concluded with all subjects’ information being complete, accurate, consistent and free from discrepancy. This key study, PF614-104, is being conducted by Dr. Vince Clinical Research. The PF614-104 trial was designed to evaluate the abuse potential, drug liking and pharmacokinetics of oral administration of PF614 versus immediate-release oxycodone HCl in non-dependent, recreational drug users. HAP studies are critical for gaining Abuse Deterrent labeling as outlined by the FDA. Unblinding of the study data began on February 27, 2023 and the Company remains on track to report results by the end of March.