Ensysce Biosciences Announces FDA Breakthrough Therapy Designation Granted for PF614-MPAR

Ensysce Biosciences, Inc. recently announced receipt of notice from the US FDA that it has granted Breakthrough Therapy Designation (BTD) 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.

BTD is a rarely used designation, having been granted to fewer than 300 drugs. It is designed to expedite the development and review of drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies.

Prescription overdose deaths in the US remain at a crisis point and the latest figures from the Centers for Disease Control indicate almost two overdose deaths per hour. Safer opioids to treat severe pain while providing protection against abuse and oral overdose are vital to reverse this tragic trend and Ensysce is forging the way with two new opioids in clinical development.

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.

Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences, said “We are highly encouraged with the receipt of Breakthrough Therapy Designation by the FDA based on the data we generated in our Phase 1 study, PF614-MPAR-101, that demonstrated our approach can provide protection from taking too many opioids orally. This is unique for the opioids class. We previously received Fast-Track Status for PF614, and this recognition of BTD for PF614-MPAR highlights the advancement we have made with our approach to treating severe pain. BTD facilitates our ability to expedite our programs through the approval processes in an efficient manner, with rolling review of both programs. We believe our goal of bringing the “next generation” of analgesics for severe pain to those in need is becoming a reality.”

The primary intent of BTD is to develop evidence needed to support approval as efficiently as possible. The designation provides all the features of Fast Track designation including accelerated approval and priority review along with intensive guidance involving senior managers on an efficient drug development program.

Ensysce Biosciences is a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPAR) platforms, the company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce’s products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, visit www.ensysce.com.