Ensysce Biosciences’ Innovative Approach to Safer Opioid Use: A Clinical Study Update

Ensysce Biosciences, Inc. ((ENSC)) announced an update on their ongoing clinical study.

Ensysce Biosciences, Inc. is conducting a clinical study titled ‘A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 When PF614 Capsule is Co Administered With Nafamostat as a Combination IR Solution and ER Capsule Formulation in Healthy Subjects.’ The study aims to assess the pharmacokinetics of oxycodone when PF614 is administered alone and with nafamostat, focusing on its potential to prevent oxycodone conversion in overdose situations. This study is significant as it explores safer opioid use.

The intervention involves PF614, an oxycodone prodrug, and Nafamostat Mesylate, a trypsin inhibitor. These are tested in both immediate-release and extended-release formulations to evaluate their effectiveness in controlling oxycodone release.

The study is designed as a non-randomized, sequential, open-label trial. It primarily aims to assess treatment effects, with no masking involved. The study is conducted in phases, with Part 1 focusing on dose identification, Part 2 on food impact, and Part 3 on multiple dosing effects.

The study began on July 8, 2024, with a primary completion date yet to be announced. The latest update was submitted on May 22, 2025. These dates are crucial for tracking the study’s progress and potential market impact.

This update could influence Ensysce Biosciences’ stock performance positively, as successful results may lead to safer opioid products, potentially increasing investor interest. Competitors in the pharmaceutical industry may also be impacted as the study progresses.

The study is ongoing, with further details available on the ClinicalTrials portal.