Ensysce Biosciences Continues Collaboration to Advance the Clinical Development of Innovative Overdose Protection Platform

New Study to Confirm Overdose Protection Across Full Dosage Range of Breakthrough Therapy Opioid PF614-MPAR

SAN DIEGO, CA / ACCESSWIRE / May 20, 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 the renewal of its collaboration with Quotient Sciences to undertake the study PF614-MPAR-102 to examine and evaluate the full commercial dose range of the PF614-MPAR drug product.

PF614-MPAR is the Company's Multi-Pill Abuse Protection (MPAR) unique combination opioid product which shuts off opioid release when too many pills are ingested, thereby stopping deliberate or accidental overdose. This ground-breaking technology has the potential to save many lives and was recently granted Breakthrough Therapy designation by the U.S. Food & Drug Administration (FDA).

The Phase 1b study, PF614-MPAR-102, will evaluate opioid release following administration of PF614-MPAR at doses of 25 mg, 50 mg and 100 mg delivered twice daily for 5 days to verify both overdose protection and effective delivery of oxycodone. The study will apply the Quotient Sciences Translational Pharmaceutics platform to manufacture and test the PF614-MPAR drug product to expedite the clinical study process.

Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, remarked, "My team is delighted to continue our partnership with Quotient Sciences and the use of their unique approach to drug product optimization. Our aim is to provide prescribers and patients with an innovative, safer choice to treat severe pain and reduce substantial concern of overdose. As prescription opioid overdoses remain a critical issue in America, the resultant regulatory restrictions are now causing supply issues for patients in severe pain. The potential benefits of our MPAR platform were highlighted by Dr. Rick Dart at the PAINWeek conference in 2023."

About Breakthrough Therapy

Breakthrough Therapy is a rarely used designation, having been granted to fewer than 300 drugs since the category was established in 2012. 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.