FDA Response Streamlines Path to Commercial Production of PF614~
SAN DIEGO, CA / ACCESS Newswire / November 20, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics designed to minimize abuse and overdose risk, today announced that the Food and Drug Administration (FDA or Agency) provided Written Responses to a meeting request.
Ensysce had requested guidance on its approach to the manufacture of PF614, wanting to understand the appropriateness of regulatory starting materials (RSMs) and specifications for PF614 drug substance and the RSMs.
In its written responses, the Agency agreed with all of Ensysce's proposed plans. These responses provide Ensysce with a direct path to commercial production of PF614, which is currently being initiated with its manufacturing partner, Purisys, LLC, a subsidiary of Noramco, LLC.
Dr. Jeff Millard, Chief Operating Officer of Ensysce who lead the CMC effort stated "We are extremely pleased with the FDA's feedback, which validates our approach and enables us to accelerate PF614's path to market. This milestone brings us closer to providing safer pain relief options for patients in need."
"The feedback from the FDA now provides us with a clear path to scaling our manufacture of PF614 for its commercial production," said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce. "PF614 is our TAAP™ oxycodone analogue and the leading product in our Next Generation Analgesic pipeline of TAAP™ and MPAR® products. We are exceptionally pleased that our meeting package was so well received and that we are aligned with the FDA requirements for producing this novel therapeutic that is designed to alleviate moderate to severe pain while providing what we believe are safer qualities for the general public who require this level of pain relief."
About Ensysce Biosciences
Ensysce Biosciences is a clinical-stage company with a goal of disrupting the analgesic landscape by introducing a new class of highly novel opioids for the treatment of severe pain. Leveraging its Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. For more information, please visit www.ensysce.com.
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