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Ensysce Biosciences Receives $14 Million NIH Grant for Clinical Development of Novel Opioid with Overdose Protection
~ Substantial Award Follows FDA Breakthrough Therapy Designation for PF614-MPAR ~~ Federal Grant Funding Awarded to Date Now at $40 Million ~ SAN DIEGO, CA /
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ Substantial Award Follows FDA Breakthrough Therapy Designation for PF614-MPAR ~~ Federal Grant Funding Awarded to Date Now at $40 Million ~ SAN DIEGO, CA / ACCESSWIRE / August 27, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) (\"Ensysce\" or the \"Company\"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced receipt of a $14 million multi-year grant from the NIH and National Institute on Drug Abuse (NIDA) for the continued development of PF614-MPAR, an abuse-deterrent opioid with overdose protection that received Breakthrough Therapy designation from the FDA in January 2024. Funding from this award will be available over a period of approximately three years, allowing for the completion of the Phase 1b clinical trial, PF614-MPAR-102. This Phase 1b study is designed to expand the product offering identified in the PF614-MPAR-101 study, the first study to verify the overdose protection of the Multi-Pill Abuse Resistance (MPAR®) platform. Combined, the two studies will help position PF614-MPAR as the first opioid product with oral overdose protection.Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences, commented, \"This non-dilutive award by NIDA is another meaningful vote of support by the federal government for the development of this novel class of opioids with overdose protection. Our initial Phase 1 study of PF614-MPAR demonstrated this approach to treat pain provides protection from taking too many pills orally. With this funding, adding to the two prior grants of over $26 million for the initial work on the MPAR and opioid use disorder (OUD) programs, Ensysce intends to quickly drive PF614-MPAR through clinical development to make its benefits available in a large market where we believe unmet need is high.\"PF614-MPAR is designed to provide optimal pain relief at prescribed doses yet limit accidental or intentional overdose by ‘shutting down' opioid release if too much active drug is consumed. PF614-MPAR could herald a new class of treatment for the most severe forms of pain and could save lives, as each capsule contains built-in protection against both abuse and overdose which plague traditional opioids. Safer opioids for severe pain which protect against abuse and oral overdose are v...