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Ensysce Biosciences Announces New Clinical Results from Trials PF614-102 and PF614-MPAR-101
~ Results confirmed the safety and longer-lasting profile of PF614 versus OxyContin and provides first human data showing the potential for overdose
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ Results confirmed the safety and longer-lasting profile of PF614 versus OxyContin and provides first human data showing the potential for overdose protection with MPAR~~ Announces corporate update call timing ~SAN DIEGO, CA / ACCESSWIRE / May 5, 2022 / Ensysce Biosciences, Inc. (\"Ensysce\" or the \"Company\") (NASDAQ:ENSC, OTC:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance with a current focus on reducing abuse and overdose, today presented results from the clinical trials PF614-102 and PF614-MPAR-101 at the SMi Pain Therapeutics meeting in London, UK.PF614-102The multi-ascending dose study (MAD) study examined 3 dose levels of PF614, a novel TAAP prodrug of oxycodone and the Company's lead candidate in Phase 2 development for the treatment moderate to severe pain. The MAD study evaluated PF614 delivered as an oral solution or as 100 mg capsules. The healthy volunteer study was designed to evaluate the safety and pharmacokinetics of five days of treatment with twice daily doses of PF614 to equivalent doses of OxyContin, the extended-release abuse deterrent formulation of oxycodone. The results of the study show the longer-lasting half-life of PF614 versus OxyContin as seen in the prior Phase 1 single-ascending dose study of PF614 oral solution versus OxyContin. The pharmacokinetic data demonstrated that PF614 has a delayed onset and extended activity after delivery, with a time to maximal drug concentration of 5.8 hour similar to Oxycontin's 4.5 hour. A distinguishing feature of PF614 is its terminal half-life which on Day 5 ranged from 13.75 to 28.4 hour as compared to 4.5 to 7.8 hour for OxyContin. We believe this data confirms the findings from our Phase 1 study that demonstrate PF614 should provide true twice daily dosing.The safety data for the study also showed that PF614 performed similarly to OxyContin with no test article serious adverse events recorded. Treatment emergent adverse events (TEAE) were limited and opioid related.The second part of the PF614-102 study, the bioequivalence (BE) arm, continues to be analyzed and as reported previously it is anticipated that this BE data will be available at the end of the second quarter of 2022.PF614-MPAR-101PF614-MPAR-101 overdose protection study examined PF614 administered orally alone or in ...