DEA Permits Further Cannabinoid-based Pharma Research
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Vitality Biopharma has received approval from both the U.S. Drug Enforcement Administration (DEA) and the State of California Research Advisory Panel which permits them to continue development of its novel cannabinoid pharmaceutical prodrugs.
Despite cannabis attaining legal status within the State of California and in many other states across the U.S. for medical and recreational purposes, pharmaceutical research and development continues to be closely regulated by the DEA and the U.S. Food and Drug Administration (FDA). Vitality initially worked with the DEA to ensure adequate on-site measures are in place to prevent diversion of Schedule I controlled substances, the most regulated tier of controlled substances in the US. In addition, the California Research Advisory Panel, a part of the California Attorney General’s Office, also approved Vitality’s cannabinoid pharmaceutical development activities.
Vitality Biopharma’s operations are in compliance with federal controlled substance regulations and are enabling development of a novel class of cannabinoid prodrugs that avoid psychoactivity. The company’s lead compound VBX-100 is a proprietary prodrug of THC that is targeted to the gastro-intestinal tract, meaning it reduces or avoids entry of THC into the bloodstream or brain. VBX-100 is produced on-site using an enzymatic biosynthesis process and will be produced according to cGMP pharmaceutical standards for use within clinical trials across the United States.
“Our biocatalysis and drug manufacturing capabilities have advanced rapidly over the past 18 months, and we’re excited to continue this work with oversight from DEA, the State of California, and also the FDA,” said Dr. Brandon Zipp, Director of R&D, and Scientific Co-founder of Vitality Biopharma.
Robert Brooke, CEO and Co-founder of Vitality Biopharma adds that, “Our team first pioneered a novel biosynthesis process for our cannabinoid prodrugs, and now they’ve successfully scaled it in a way that could enable widespread supply for clinical trials and even commercialization. This puts us in an enviable position within our industry, and we look forward to seeing what else can be achieved in the months and year ahead.”