Overland Park, KS., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Dr. Vince Clinical Research (DVCR), a world-class early phase contract research organization (CRO) specializing in the conduct of Phase I clinical trials, today announced that it has administered the first dose in Ensysce Bioscience’s oral Human Abuse Potential (HAP) study in recreational drug users.
“I am excited to partner with DVCR on this critical program as we evaluate oral abuse potential of our PF614 product. Dr. Vince has built an impressive clinical pharmacology unit and has put together an exceptionally strong team of individuals with significant expertise in the conduct of these very specialized trials,” said Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences.
CNS-active new molecular entities (NMEs) are subject to an abuse potential evaluation and this evaluation may require a pivotal HAP study. This particular study will examine the desirability of three doses of PF614 versus a current marketed equivalent and placebo in recreational drug users. Eligible subjects will receive five treatments (one per treatment period) in a randomized, double-blind, crossover manner. The primary outcome measure will be ‘Drug Liking’ and the key secondary endpoint will be ‘Take Drug Again’. Less drug liking is believed to relate to less abuse potential for a new product.
“Throughout my career, I have conducted a significant number of Abuse Liability clinical trials with both industry sponsors and government entities,” said Dr. Brad Vince, CEO and Medical Director. “My significant experience in this area gives us a unique opportunity to more efficiently and effectively conduct these complex studies. We continue to invest in training, technology and our research team in order to provide the cleanest data possible to our biopharmaceutical clients specifically for studies of this nature.”
About Dr. Vince Clinical Research
Dr. Vince Clinical Research (DVCR) is a world-class CRO (Contract Research Organization) with a custom-built, green-designed headquarters and research complex encompassing three buildings in Overland Park, KS. DVCR’s complex includes a 90-bed clinical pharmacology unit featuring a combination of luxurious and private research suites and a GMP compliant pharmacy with positive and negative pressure compounding rooms. DVCR specializes in conducting clinical trials for both healthy normal volunteers and patient populations in a wide variety of early phase trials. By leveraging both technology and one of the country’s most experienced leadership teams, DVCR provides Smarter, Faster Data to their biopharmaceutical clients.
About Ensysce:
Ensysce 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 (MPARTM) 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 overdose. Our products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse, reducing the human and economic costs. 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.
