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Ensysce Biosciences Announces Treatment of First Cohort for Subjects in Clinical Study of its Next Generation Opioid, PF614
Company Commences Second Study of Trypsin Activated Abuse Protected (TAAP) Opioid, PF614, on September 7, 2021 SAN DIEGO, Sept. 08, 2021 (GLOBE NEWSWIRE) --
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"Company Commences Second Study of Trypsin Activated Abuse Protected (TAAP) Opioid, PF614, on September 7, 2021\nSAN DIEGO, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Ensysce Biosciences, Inc. (“Ensysce” or the “Company”) (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company with proprietary technology platforms to reduce the economic and social burden of prescription drug abuse and overdose, today announced that it has enrolled the first cohort of subjects in a clinical study PF614-102 entitled “A Phase 1b, Randomized, 2-Part Single-Center Study to Evaluate the Pharmacokinetics and Safety of Multiple-Ascending Oral Doses of PF614 and the Food Effect and Bioavailability/Bioequivalence of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects.” The study is being conducted by Matthew Johnston, MD, PRA Health Sciences, Salt Lake City, Utah. PF614 is designed as an extended-release oxycodone prodrug with trypsin-activated abuse protection (TAAP). TAAP chemical modification inactivates the active ingredient in Ensysce’s opioids products including PF614 and provides abuse deterrence, resistance to manipulation and other forms of recreational drug abuse, while providing a high degree of pain relief for those in severe pain. This study will build on the safety and pharmacokinetic results of the initial Phase 1 study, and may lead to an understanding of how PF614 compares to currently available commercial products. “Finding a safe and effective treatment to address the opioid crisis is a pressing health priority,” said Dr. William Schmidt, Chief Medical Officer of Ensysce. “This study will be an important step toward achieving our goal of developing the next generation of opioid products for patients in chronic pain.” “This important study, to demonstrate how PF614 compares to OxyContin, may lead to the ability to use the 505(b)(2) regulatory path to registration, and the more seamless commercialization of this highly innovative approach to reduce opioid abuse.” said David Kovacs, VP of Public Policy. “I joined this team because I believe these products may provide an opportunity to change the course of this huge societal problem.” Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences, commented: “Our mission is to transform pain treatment and provide a critical solution to the opioid crisis. We believe our approach can con...