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Ensysce Biosciences Reports Fourth Quarter and Full Year 2022 Financial Results
~ Corporate Update Call to be Held Tuesday, April 11, 2023 ~SAN DIEGO, CA / ACCESSWIRE / March 30, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ Corporate Update Call to be Held Tuesday, April 11, 2023 ~SAN DIEGO, CA / ACCESSWIRE / March 30, 2023 / Ensysce Biosciences, Inc. (\"Ensysce\" or the \"Company\") (NASDAQ:ENSC), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety, today reported financial results for the fourth quarter and full year of 2022.Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, \"Our focus remains on execution and advancing clinical development plans for our programs that provide strong pain relief using our PF614 and PF614-MPAR drug products. This has been evident in the recently released news regarding completion of enrollment of our first PF614-MPAR study and completion of the clinical stage of two human abuse potential studies for PF614. These studies add to the clinical support demonstrating that Ensysce has a novel approach for delivering effective pain management and safely alleviating severe pain in patients requiring an opioid analgesic. These recent accomplishments move us closer to our Phase 3 plans and toward bringing what we believe is the ‘Next Generation of Analgesia' for severe pain to commercialization.\"TAAPTM (Opioid Abuse Deterrent Program) UpdatesOur lead program, PF614 is a \"Trypsin-Activated Abuse Protection\" (TAAPTM) extended-release oxycodone. The Company's TAAPTM technology is designed to control release, be highly resistant to tampering, and reduce abuse through a unique chemical modification that is activated by trypsin. The achievements highlighted below advance the company toward Phase 3 clinical evaluation.On February 28, 2023, the Company announced the database lock for the oral Human Abuse Potential (HAP) study of PF614. With the database lock, no further change to the trial data is permissible.On January 4, 2023, the Company announced that it had successfully completed the clinical portion of study PF614-104, ‘A Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Oral Abuse Potential of PF614 Compared with Oxycodone Immediate-Release Tablets, and Placebo in Non-Dependent Recreational Opioid Users' (ClinicalTrials.gov: NCT05571345) conducted by Dr. Vince Clinical Research.On November 14, 2022, the Company announced that it received written guidance from the FDA that an acute pain indication may be appropriat...