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~ Advanced Preparation for New Drug Application ~
SAN DIEGO, CA / ACCESS Newswire / May 12, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for abuse and overdose, today announced it has added Tracy Hysong, CCRA as Senior Director of Regulatory Affairs to its management team.
Ms. Hysong is a Certified Clinical Research Associate (CCRA) through the Association of Clinical Research Professionals with years of experience undertaking regulatory activity at the University of California Davis (UC Davis). She helped establish the UC Davis Clinical Trials Office as part of the Clinical and Translational Science Center (CTSC) at UC Davis Health. Her expertise will bolster the regulatory team at Ensysce as the Company focuses on the execution of multiple clinical trials. Over the next year, Ensysce will be initiating its Phase 3 pivotal study to evaluate the efficacy of PF614 and develop its New Drug Application (NDA) for submission in 2026. Additionally, Ensysce has ongoing clinical studies to evaluate a groundbreaking overdose-protected pain medicine, PF614-MPAR, and is preparing for an Investigational New Drug (IND) Application and Phase 1 study of its novel treatment for opioid use disorder (OUD).
Dr. Lynn Kirkpatrick, CEO of Ensysce, added, "The ability to bring Tracy on board at this time is crucial for the Company as it handles three current INDs, prepares to submit a fourth IND for PF9001 for OUD, and plans the regulatory submission of an NDA for PF614. Tracy's experience with clinical trial support and regulatory affairs is perfectly timed to meet the Company's needs going forward. As recently reported, we believe our highly novel treatment of OUD, with both abuse deterrence and overdose protection built in, will be moving through IND-enabling studies and IND submission in the coming year, in addition to the parallel regulatory activities associated with PF614 and PF614-MPAR. We welcome this addition of Tracy to our team."
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 (TAAPTM) 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.