Ensysce Biosciences Inc. (NASDAQ: ENSC) announced it received Investigational Review Board approval to begin Part 3 of the PF614-MPAR-102 clinical study, the final stage of testing for its overdose-protection technology.

The study evaluates PF614-MPAR, an opioid formulation that received Breakthrough Therapy designation from the U.S. Food and Drug Administration. The drug uses what the company calls Multi-Pill Abuse Resistance technology, designed to maintain therapeutic opioid levels during prescribed use while limiting additional opioid release when excessive doses are taken.

According to previously published clinical data, PF614-MPAR delivers consistent plasma levels under normal dosing while reducing opioid exposure at higher-than-prescribed doses. Part 3 of the study will examine this protective effect across different dosing scenarios.

"Nearly 80,000 lives are lost annually to opioid overdose in the U.S., with prescription opioids contributing meaningfully to this ongoing crisis," said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce. "MPAR introduces a new class of chemically engineered opioids designed to actively protect patients, even in cases of dosing errors or misuse."

The study continues formulation development with support from the National Institute on Drug Abuse. Ensysce is also exploring applications of the MPAR technology for amphetamines and methadone treatments for pain, attention-deficit/hyperactivity disorder, and opioid use disorder.

The San Diego-based clinical-stage pharmaceutical company develops pain and central nervous system treatments designed to minimize abuse and overdose risk. Information is based on a company press release.