Ensysce Biosciences announces FDA feedback on PF614-MPAR development

Ensysce Biosciences (ENSC) received feedback and constructive guidance from the U.S. Food and Drug Administration on the development of PF614-MPAR, the Company’s first-of-its-kind opioid analgesic designed with both abuse deterrence and overdose protection. PF614-MPAR has earned the FDA’s Breakthrough Therapy designation and is uniquely engineered using Ensysce’s proprietary TAAP and MPAR technologies. These platforms are uniquely engineered to maintain powerful pain relief while automatically activating built-in overdose protection if a patient exceeds the prescribed dose-whether accidentally or intentionally. The FDA meeting held July 23, 2025, focused on the clinical and non-clinical roadmap for PF614-MPAR’s approval, with a key emphasis on achieving overdose protection labeling. Both Ensysce and the FDA aligned on a collaborative approach to ensure the product’s safety benefits are appropriately recognized. This includes Ensysce working with the FDA to develop a whitepaper on Overdose Protection, while continuing to develop PF614-MPAR. The meeting provided guidance on non-clinical, clinical and manufacturing questions that the Company had posed to the agency, and it also confirmed that PF614-MPAR may be eligible to pursue a streamlined 505(b)(2) regulatory pathway, potentially accelerating its time to market. “This milestone brings us closer than ever to delivering a new class of opioid analgesics that not only provide critical pain relief but also protect patients from the devastating risks of overdose,” said Dr. Lynn Kirkpatrick, CEO. “MPAR technology is designed to save lives. While we are initially applying it to opioid pain medications, we also see significant potential in addressing overdose risks in opioid use disorder and ADHD treatments. Our goal is to transform how medicines are designed so that the drugs in every household medicine cabinet are inherently safer.”