Ensysce completes clinical portion of oral human abuse potential trial

Ensysce Biosciences has completed the clinical portion of study PF614-104, ‘A Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Oral Abuse Potential of PF614 Compared with Oxycodone Immediate-Release Tablets, and Placebo in Non-Dependent Recreational Opioid Users’ being conducted by Dr. Vince Clinical Research. This is the second human abuse potential study completed for PF614, a controlled-release oxycodone TAAPa prodrug, following completion of an intranasal HAP study in August 2022. HAP studies are critical for gaining abuse-deterrent labeling as outlined by the FDA. The trial was designed to evaluate abuse potential in non-dependent, recreational drug users, including measures of "drug liking" and whether study participants would "take drug again." Orally administered PF614 was compared to immediate-release oxycodone HCl. The global opioid epidemic is primarily driven by individuals abusing opioids through manipulation of currently marketed products. PF614 is designed to maintain its extended-release profile even after being subjected to common methods of manipulation, including chewing and crushing the product prior to oral administration. The PF614-104 study examined the ‘Drug Liking’ as well as pharmacokinetic release of oxycodone from each test agent, including PF614, oxycodone HCl, and placebo, all administered orally in a blinded rotation among 32 recreational drug users. The primary outcome measure is the maximum effect for ‘Drug Liking.’ Data from the clinical trial is expected to be released in March 2023.