Ensysce Biosciences Secures FDA Breakthrough Therapy Designation and Advances Regulatory Review for Opioid with Overdose Protection, Supported by NIDA Grants

Reuters07-31

Ensysce Biosciences Secures FDA Breakthrough Therapy Designation and Advances Regulatory Review for Opioid with Overdose Protection, Supported by NIDA Grants

Ensysce Biosciences Inc., a clinical-stage pharmaceutical innovator, has announced positive feedback and guidance from the U.S. Food and Drug Administration (FDA) regarding their novel opioid analgesic, PF614-MPAR, designed with both abuse deterrence and overdose protection. Following a productive meeting with the FDA, Ensysce is advancing towards achieving overdose protection labeling and may pursue a streamlined 505(b)(2) regulatory pathway. This could potentially accelerate the market introduction of PF614-MPAR. The development of this breakthrough opioid is supported by multi-year grants from the National Institute on Drug Abuse (NIDA), with the most recent funding awarded in 2024, continuing through May 2027. This collaboration aims to enhance opioid safety by integrating built-in overdose protection, potentially transforming pain management practices.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ensysce Biosciences Inc. published the original content used to generate this news brief on July 31, 2025, and is solely responsible for the information contained therein.

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