Ensysce Biosciences announced receipt of notice from the U.S Food and Drug Administration that it has granted Breakthrough Therapy Designation for PF614-MPAR. A next generation opioid, PF614-MPAR represents a major scientific innovation, as it is what we believe to be the first product with oral overdose protection in any drug class. 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 if approved, as each capsule contains built-in protection against both abuse and overdose which plague traditional opioids.
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