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Canadian licensed marijuana producer Tilray Inc. has received the green light from the U.S. Drug Enforcement Administration agency to export a medical cannabis product south of the border for use in a clinical trial.
The Nanaimo, B.C.-based company and a researcher at the University of California San Diego believe it is the first export of a cannabis study drug from a Canadian company to the U.S., where marijuana is still illegal at the federal level.
Tilray will be exporting capsules containing a cannabinoid formulation with the active ingredients cannabidiol and tetrahydrocannabinol, better known as CBD and THC, for a study examining the drug as a potential treatment for adults with essential tremor.
Getting the approval was a months-long process and required an OK from the Food and Drug Administration and the U.S. DEA, said Dr. Fatta Nahab, a neurologist and associate professor of neurosciences at UC San Diego’s medical school.
“This is an oral capsule formulation that has actual plant in it,” he said. “It’s a purified, medical-grade formulation, and to my knowledge, that’s never been imported from Canada before.”
While Canada has had a legal framework for medical marijuana for years and the country is preparing to legalize cannabis for recreational use next month, the drug’s legal status south of the border is murky.
Several states have legalized cannabis for medical or recreational use, but marijuana remains an illegal schedule 1 drug under U.S. federal law. Earlier this year, U.S. Attorney General Jeff Sessions rescinded an Obama-era memo that suggested that the federal government would not intervene in states where cannabis is legal. However, a U.S. senate bill was introduced in June that would amend the Controlled Substances Act to exempt marijuana activity that is legal at the state level.
Still, the legal landscape for the drug south of the border not only complicates matters for companies looking to operate in the U.S., it is a hurdle for research as well.
Historically, the cannabis used in U.S. research was available through the National Institute on Drug Abuse (NIDA), and it was in form such as dried bud that needed to be smoked or vaporized, Nahab said. In those forms, it is difficult to control the dosage, he said, adding that NIDA does not have an oral formulation.
This is believed to be the first study drug imported from Canada to the U.S., said Dr. Catherine Jacobson, Tilray’s director of clinical research, who is based in California.
“It’s quite significant... this is the first time a Canadian (licensed producer) has demonstrated to the FDA that a study drug produced in Canada from the cannabis plant can meet its standards,” she said.
Nahab’s team reached out to four different companies, including in the U.S., and selected Tilray.
“We’ve got a set dosing, fixed, highly consistent, and so it’s really going to help us advance the field much more,” he said.
The study on essential tremor, a common neurological disorder which causes a part of a person’s body to shake involuntarily, was partially funded by Tilray and the International Essential Tremor Foundation.
The clinical trial with 16 adult participants who have been diagnosed with essential tremor is expected to begin in 2019, and will take approximately one year to complete.
Tilray will not have any proprietary claim to the results, and it is largely an unfunded study, Nahab said.
The next step is to receive an appropriate license from Health Canada. Tilray says an application has been submitted, and they expect to receive it in a couple of weeks.