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Ensysce Biosciences Announces Successful Completion of Clinical Portion of Oral Human Abuse Potential Trial
Data Expected in March 2023SAN DIEGO, CA / ACCESSWIRE / January 4, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC, OTC:ENSCW), a
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"Data Expected in March 2023SAN DIEGO, CA / ACCESSWIRE / January 4, 2023 / Ensysce Biosciences, Inc. (\"Ensysce\" or the \"Company\") (NASDAQ:ENSC, OTC:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, today announced that it has successfully 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' (ClinicalTrials.gov: NCT05571345) being conducted by Dr. Vince Clinical Research.This is the second human abuse potential (HAP) study completed for PF614, a controlled-release oxycodone TAAPä 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 (ER) profile even after being subjected to common methods of manipulation, including chewing and crushing the product prior to oral administration.Dr. Lynn Kirkpatrick, CEO of Ensysce, commented, \"Release of the active ingredient in PF614 requires exposure to trypsin, which is found only in the small intestine and not in the mouth, the nose, or blood stream, so simple manipulation of PF614 will not result in oxycodone release. We are looking forward to reporting the final data from this oral PF614-104 trial and expect to do so by the end of the first quarter.\"Dr. William Schmidt, Chief Medical Officer of Ensysce, stated, \"We believe that this oral HAP study will provide critical data to differentiate PF614 from other oxycodone ER products that can be abused through crushing and chewing to convert to immediate release products. This study along with our previously reported positive nasal HAP study represents two essential steps toward achievi...