Tilray gains U.S. government approval to import a medical cannabis study drug

Canadian marijuana imports OK'd by US for California study

The news signals yet "another encouraging sign of improved government support for cannabis research", Cowen analyst Vivien Azer said in a note, Bloomberg reports.

Despite medical marijuana being legal and available through dispensaries in 30 states and the District of Columbia, it remains federally illegal, and researchers must complete lengthy applications through the for new research projects.

"It's a really big milestone for Tilray and also just for the whole industry", said Catherine Jacobson, Tilray's director of clinical research. Unlike Parkinson's disease, which causes shaking when someone is not moving, people with essential tremors shake when they are, making everyday activities like writing, drinking and speaking hard.

Cannabis plants at Tilray in Nanaimo, B.C.

Cannabis is a Schedule 1 drug, as defined by the Drug Enforcement Administration (DEA), and availability for research purposes is strictly limited.

They want to study the drug's effectiveness in treating tremors that afflict millions of people.

Shares in marijuana company Tilray Inc. went on a wild ride - surging by more than 90 per cent then briefly dropping into negative territory and rebounding - one day after the licensed producer said it got approval to export medical cannabis from Canada to the US for a clinical trial.

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Fatta Nahab, a neurologist at UC San Diego and the principal investigator for the study, said his first exposure to the idea of using cannabis to treat the disorder came a few years ago when a young male patient who he'd been tracking suddenly showed an improvement in his tremors. "There are definitely situations where, when there's no source in the US, a registrant can import a cannabis-derived drug from another country". "If this study can identify cannabinoids as a potential treatment for patients suffering from essential tremor, we can conduct further research and potentially provide alternative effective methods of relief for the high numbers of patients with essential tremor". "The oral combination of CBD and THC is the first-of-its-kind to be studied and is especially interesting to CMCR".

The university hopes to have 16 to 20 patients in the study, which will begin early next year.

The National Institute on Drug Abuse usually provides marijuana as bulk flower or joints to be vaporized or smoked. The pill being developed with Tilray will be a hard capsule and will allow for better oversight in dosing, he said. Researchers monitor the tremors with a device placed on the wrist and will record changes in the severity of the shaking, among other things.

"This trial should help answer many of these critical questions".

Tilray is providing the drug and limited financial support but said it will have no role in reviewing the study's results.

Historically, the cannabis used in US 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.

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