Vitality Biopharma, Inc., a corporation dedicated to the development of cannabinoid prodrug pharmaceuticals, announced that it has received approval from both the U.S. Drug Enforcement Agency (DEA) and the State of California Research Advisory Panel which permits the company to scale up activities at its facilities used for the development of novel cannabinoid pharmaceutical prodrugs.
Vitality has been working with the DEA to ensure adequate on-site measures are in place to prevent diversion of Schedule I controlled substances. As a component of this process, Vitality’s preclinical studies for its proprietary prodrugs of CBD and THC were reviewed and approved by the U.S. Food & Drug Administration (FDA). The California Research Advisory Panel, a part of the California Attorney General’s Office, has also granted Vitality a research permit to conduct cannabinoid pharmaceutical development activities that are designed to enable regulatory approval of first-in-man clinical trials.
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 FDA. Vitality’s work is focused on developing a novel class of THC and CBD prodrugs that reduce or avoid psychoactive side effects through targeted prodrug technology.
“We are excited to scale up our research and to aggressively pursue clinical testing of our compounds, and this approval greenlights that work,” said Dr. Brandon Zipp, Director of R&D, and Scientific Co-founder of Vitality Biopharma. Robert Brooke, the company’s CEO, further states that, “There are surprisingly few companies in the United States that are properly licensed and developing differentiated cannabinoid pharmaceutical products. We are very proud of our team’s work to enable this milestone, and believe that recent discoveries have provided us with a very unique opportunity.”