Opioid Developer Ensysce Biosciences Stock Is Shooting Higher Today - Here's Why

Ensysce Biosciences Inc (NASDAQ:ENSC) received an FDA Breakthrough Therapy Designation (BTD) for PF614-MPAR, a next-generation opioid.

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

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. 

Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences, commented, “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.”

Ensysce Biosciences is a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs. 

It leverages its Trypsin-Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPAR) platforms to develop tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. 

In December, Ensysce Biosciences announced that its study demonstrated crucially important data for PF614 on pain intensity efficacy and speed of onset.

PF614 demonstrated time-to-efficacy onset for the analgesic effect and a significant decrease of pain intensity versus placebo of PF614 at two different dose levels, the first ever measured for this TAAP opioid.

Price Action: ENSC shares are up 42.20% at $1.62 on the last check Tuesday.

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