Nanaimo firm exporting pot for clinical trials in U.S.

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-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 approvals 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.

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.

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 one year to complete.

Tilray will not have any proprietary claim to the results, and it is largely an unfunded study.