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Ensysce Biosciences Announces Positive Topline Results of Clinical Study Evaluating Human Abuse Potential of Intranasal Administration of PF614, a TAAP Abuse-Deterrent Oxycodone Extended-Release Product
~ Announces Timing of Corporate Update Call ~SAN DIEGO, CA / ACCESSWIRE / October 31, 2022 / Ensysce Biosciences Inc. ("Ensysce" or the "Company")
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ Announces Timing of Corporate Update Call ~SAN DIEGO, CA / ACCESSWIRE / October 31, 2022 / Ensysce Biosciences Inc. (\"Ensysce\" or the \"Company\") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety focused on reducing abuse and overdose, today announced positive topline results from a human abuse potential (HAP) study for PF614. PF614 is a new class of analgesia, a Trypsin Activated Abuse-Protected oxycodone product. Ensysce's TAAPTM technology is designed to be highly resistant to tampering and abuse as compared to traditional Abuse Deterrent Formulations (ADFs) of oxycodone. The product's abuse-deterrent characteristics are being evaluated in laboratory and clinical studies, consistent with the 2015 FDA Guidance for labeling. The HAP study was designed to test if known recreational drug users \"liked\" the product and is critical for new drugs in this class. The primary measure in this study, \"drug liking,\" is recommended by the FDA in their Guidance on \"Assessment of Abuse Potential of Drugs.\" This measure is known to correlate with a drug's potential for abuse.Intranasal administration of PF614 powder from capsule was compared with intranasal administration of crushed oxycodone immediate-release (IR) tablets in non-dependent, recreational opioid users (n=26). The primary endpoint for the study was \"drug liking at this moment,\" measured up to 24 hours after dosing using a visual analogue scale (VAS). In the study, PF614 powder produced significantly lower peak \"drug liking\" (Emax) when compared with intranasal crushed IR oxycodone (p = 0.0133) using the full modified completer population in a 3-period crossover of PF614 vs. crushed oxycodone and placebo. Furthermore, in a first period analysis of initial impressions of each drug, a similarly strong difference was noted between PF614 (n=8) and crushed IR oxycodone (n=10) (p = 0.0175), even with this smaller cohort of subjects.Statistically significant differences in peak effects (Emax) between PF614 and crushed IR oxycodone intranasal were also demonstrated for the secondary endpoint of \"take drug again,\" also using a first period analysis, where PF614 produced only 27% as high an Emax score as crushed oxycodone among recreational drug users (p \"We are very excited about the resul...