CURE Pharmaceutical Holding Corp. Augments Its Existing U.S. DEA License in Order to Initiate Development of Its Psychedelics-Based Pharmaceutical Clinical Pipeline
March 23, 2021 at 06:00 pm IST
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CURE Pharmaceutical Holding Corp. announced that it has secured an extension to its Schedule I U.S. Drug Enforcement Agency (DEA) license that will allow the Company to conduct research on psychedelics-based pharmaceuticals using compounds such as LSD, MDMA, and psilocybin as potential treatments for various mental health disorders. The license enables CURE to conduct fully integrated research at its facility utilizing leading compounds and its patented delivery platform, seeking innovative solutions in high-impact and unmet patient need areas. Schedule I licenses are granted to companies with the qualifications and research protocols for the handling of drug substances with no accepted medical use and a high potential for abuse. Obtaining this type of license is a rigorous process, requiring a well-documented scientific investigation in a formal application, inspection of laboratory facilities and confirmation of facility security. CURE’s existing DEA license allows the company to manufacture cannabinoid-based pharmaceuticals. Last year, CURE used this license to complete a pharmacokinetic study of its preliminary 25mg cannabidiol (CBD) oral film showing improved bioavailability of CBD in healthy subjects when compared to 25mg soft gels. The study showed significantly higher serum concentration (Cmax) and significantly faster absorption (Tmax) comparing CURE's CBD oral film dosage form to a commercially available CBD soft gel. Further research on psychedelic compounds as potential treatments for mental health disorders has gained significant interest in last few years. There is promising research being conducted at the private, academic, and federal level on treatment of depression, PTSD, addiction disorders, obsessive compulsive disorder, and anxiety.
Avenir Wellness Solutions, Inc. is a platform technology company. The Company develops proprietary wellness, nutraceutical, and topical delivery systems. The Company is focused on the development of nutraceutical formulation and delivery technologies in novel dosage forms to improve wellness. Its wholly owned subsidiary, The Sera Labs, Inc. (Sera Labs), is engaged the development, production and sale of the Companyâs wellness and beauty products. Sera Labs creates products that use science-backed, proprietary oral and topical formulations. The Company sells over 25 products under the brand names Seratopical, Seratopical Revolution SeraLabs, and Nutri-Stri. Sera Labs products are sold direct-to-consumer via online Website orders, including opt-in subscribe and save option, and also online and in-store at national drug, mass retailers, grocery chains and convenience stores and on Amazon.com.
CURE Pharmaceutical Holding Corp. Augments Its Existing U.S. DEA License in Order to Initiate Development of Its Psychedelics-Based Pharmaceutical Clinical Pipeline