A licensed marijuana producer based in Nanaimo has received approval to export a medical cannabis product to the USA for a clinical trial.
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.
The capsules will be manufactured as pills by Canada-based Tilray Inc., and will be used to treat essential tremor, a neurological disorder that causes shaking in the hands, head and voice, and is believed to affect almost 10 million Americans, especially those over the age of 65.
Marijuana is illegal under federal law, but the USA has a program for supplying it for research.
NIDA doesn't offer capsules, so the researchers spent about two years going through regulatory hoops to obtain permission to import the drug from Canada, where medical marijuana is federally legal and where recreational sales begin nationwide next month.
Neither the FDA nor the DEA had immediate details on how often the agencies have approved the import or use of foreign-made cannabis drugs in research, but DEA spokeswoman Katherine Pfaff says: "It is done".
UC San Diego's Dr. Fatta Nahab said he believes this product has not been imported from Canada into the US before.
NIDA, which does intend to expand how much marijuana the University of MS grows for research, does not yet provide marijuana compounds in capsules, said Don Stanford, assistant director of the Research Institute of Pharmaceutical Sciences at the university.
Researchers from the University of California, San Diego said Tuesday they received approval from the Drug Enforcement Administration and the to import a unique formula of cannabidiol and low-dose tetrahydrocannabinol, known as CBD and THC, respectively.
The Nanaimo company says many patients don't get relief with current drugs to treat ET or find the side-effects are too harsh.
There is no specific drug to treat essential tremor, a shaking condition. "The oral combination of CBD and THC is the first-of-its-kind to be studied and is especially interesting to CMCR".
Paul Armentano, deputy director of the marijuana law reform organization NORML, said that illustrated how badly American researchers need alternative sources for cannabis. "There are definitely situations where, when there's no source in the US, a registrant can import a cannabis-derived drug from another country".
"This trial should help answer many of these critical questions".
"We are extremely enthusiastic about the initiation of this study, extending as it does CMCR's program to discover therapeutic potential of various cannabinoid preparations", said Dr. Igor Grant, Center for Medicinal Cannabis Research Director.
Yet marijuana for study is typically only available in dry-bud form or cigarettes, cultivated at the University of MS and provided via the National Institute on Drug Abuse. Nahab estimates that researchers will have results in 2020.