Marijuana Business Magazine April 2020

Marijuana Business Magazine | April 2020 78 T he U.S. Food and Drug Administration is approving a growing number of applications from cannabis companies looking to conduct clinical trials studying medical marijuana. That development could lead to multiple cannabis-based medicines— including flower—receiving FDA approval to be commercialized and sold within the next five years. While attitudes might be changing at the FDA, obtaining agency approval and launching cannabis studies remain extremely difficult. But it’s not impossible, as a handful of companies have demonstrated, and certain steps can smooth the way. In June 2018, GW Pharmaceuticals’ Epidiolex, used to treat certain forms of epilepsy, became the first cannabis- plant-based medicine to receive FDA approval for commercialization (a small number of FDA-approved synthetic cannabis drugs are sold by prescription). But Cambridge, England- based GW might not be alone for long. CT Pharma, a licensed producer in Connecticut, and Tetra Bio-Pharma, a biopharmaceutical company in Ontario, Canada, both have started FDA-approved clinical trials they hope will result in cannabis drugs approved by the agency. Other major cannabis companies, including multistate players Columbia Care and Vireo Health—plus British Columbia-based producer Tilray—also are sponsoring FDA-approved studies focused on the safety and/or effectiveness of medical cannabis. Companies that have secured the FDA’s blessings have taken unique paths. But there are several shared strategies among them: • Research, rather than a focus on producing recreational products. • A researcher on the team who already has successfully petitioned the FDA to conduct drug- development studies. • Extensive testing and data collection. • Wide-ranging and meticulous recordkeeping. • Transparency. Getting FDA approval to study cannabis requires time, patience and capital. But the potential payoff that comes with having an FDA-approved pharmaceutical product on the market could rival or even dwarf what the most successful recreational marijuana companies are making. Marijuana Business Magazine spoke with two cannabis companies about what it takes to launch an FDA-approved study. CTPharma now has three studies with the Yale School of Medicine, one of which is a “groundbreaking” FDA-approved clinical study to examine stress and pain relief in human patients. Courtesy Photo Anti-seizure medication Epidiolex became the first cannabis-based medicine to receive approval in the United States in 2018. Since then, the U.S. Food and Drug Administration has approved a handful of applications for clinical trials to study medical marijuana. Companies that have gotten the FDA’s blessing for studies recommend that others: • Attend international cannabis sci- ence conferences to network with universities, hospitals and pharma- ceutical companies. • Find a researcher for the team who already has successfully petitioned the FDA to conduct drug-develop- ment studies. • Keep detailed records of cultivation practices, cleaning logs and facility layout as well as the results of po- tency and stability tests. • Know that the University of Mis- sissippi is the only FDA-approved source of cannabis for study. If you plan to use another source, be pre- pared to get clearance from the U.S. Drug Enforcement Administration. • Be aware that regulators will want to know as much about the safety of your drug-delivery method as the drug itself.