Business
Ensysce Biosciences Completes Scale Up Manufacture of PF614 to Support Phase 3 Studies
~ Positioning Company to Commence Commercialization Strategy ~SAN DIEGO, CA / ACCESSWIRE / September 14, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ Positioning Company to Commence Commercialization Strategy ~SAN DIEGO, CA / ACCESSWIRE / September 14, 2023 / Ensysce Biosciences, Inc. (\"Ensysce\" or the \"Company\") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced that two scale up manufactures have been completed for the Company's lead drug candidate PF614, a next generation pain medicine to treat severe pain. The success of the scaled manufacturing work has positioned the Company to begin its commercialization strategy consistent with timeline expectations.As a result of the positive progress on its clinical milestones, Ensysce has commenced the next phase of development, including planning its phase 3 studies and increasing its manufacturing capacity in line with commercial readiness. The previous clinical milestones met for PF614 over the past year include PF614 delivered oxycodone in an equivalent manner to Oxycodin to treat severe pain (defined as ‘bioequivalence'), yet notably PF614 had significantly lower scores of \"Drug Liking\" and ‘Take Drug Again' than its oxycodone comparator in two different recreational drug abuse studies indicating that it was less likely to be abused by drug users.Using two different Contract Manufacturing Organizations, Veranova and Purisys LLC, Ensysce has completed the manufacture of over 10 kilograms of the active pharmaceutical ingredient that will be used for the final stages of non-clinical studies, the final clinical trials that will lead to filing its New Drug Application and drug product manufacture. It is intended that Purisys LLC will continue to support the Company's larger scale commercial manufacture going forward.Dr. Lynn Kirkpatrick, CEO of Ensysce said, \"We continue to make advancements towards the final clinical trials as evident in our ability to scale our manufacturing and progress on clinical trials to date. We have found the drug substance to be robust and stable which has allowed us to press forward with our last stage clinical plans. Today, we can confidently state, we believe we have a product with equivalent efficacy to OxyContin yet with many advantages that will make it desirable to prescribe for severe pain.\"About PF614PF614 is a Trypsin Activated Abuse Protected (TAAPTM) product designed as a delayed onset extended-release oxycod...