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Ensysce Biosciences Announces Critical Step in Human Abuse Potential Study of PF614 With Database Lock
Company Remains on Track to Report Results the End of MarchSAN DIEGO, CA / ACCESSWIRE / February 28, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"Company Remains on Track to Report Results the End of MarchSAN DIEGO, CA / ACCESSWIRE / February 28, 2023 / Ensysce Biosciences, Inc. (\"Ensysce\" or the \"Company\") (NASDAQ:ENSC), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, today announced the database lock on February 24, 2023 for the oral Human Abuse Potential (HAP) study of PF614. PF614 is a TAAP™ (Trypsin Activated Abuse Protection) product to treat severe pain. With the database lock, no further change to the trial data is permissible such that all clinical trial data is concluded with all subjects' information being complete, accurate, consistent and free from discrepancy. This key study, PF614-104, is being conducted by Dr. Vince Clinical Research.The PF614-104 trial was designed to evaluate the abuse potential, drug liking and pharmacokinetics of oral administration of PF614 (controlled-release oxycodone TAAP™ prodrug) versus immediate-release oxycodone HCl in non-dependent, recreational drug users. HAP studies are critical for gaining Abuse Deterrent labeling as outlined by the FDA. Unblinding of the study data began on February 27, 2023 and the Company remains on track to report results by the end of March.About Ensysce BiosciencesEnsysce Biosciences is a clinical-stage biotech company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPAR™) platforms, the Company is in the process of developing a unique, tamper-proof treatment option for pain that minimizes the risk of both drug abuse and overdoses. 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. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com.Forward-Looking StatementsStatements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, th...