A licensed marijuana producer based in Nanaimo has received approval to export a medical cannabis product to the U.S. for a clinical trial.
Tilray Inc. announced Tuesday morning the U.S. Drug Enforcement Administration (DEA) gave the green light to allow the University of California San Diego (UCSD) to import a cannabinoid study drug from Canada.
It will be used to examine its safety, tolerability and effectiveness for treatment of Essential Tremor (ET) in adults.
Tilray will export capsules with a cannabinoid formulation with two active ingredients extracted from cannabis plants known as cannabidiol (CBD) and tetrahydrocannabinol (THC).
It is believed this is the first time a Canadian company has been approved to export a cannabis study drug south of the border.
Although marijuana has been legalized for recreational or medical use in several states, it remains illegal at the federal level.
ET is a neurological movement disorder characterized by involuntary and rhythmic shaking.
Tilray says 0.4 per cent of the general population suffers ET, which climbs to 4.6 to 6.3 per cent among those 65 and older.
The Nanaimo company says many patients don’t get relief with current drugs to treat ET or find the side-effects are too harsh.
“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 ET,” Tilray’s Director of Clinical Research Dr. Catherine Jacobson said in a statement.
UCSD researcher Dr. Fatta Nahab said his team reached out to four different companies, including in the U.S, and selected Tilray.
Nahab says Tilray will not have any proprietary claim to results of the ET study, which he says is largely unfunded.
The clinical trial is expected to begin next year and will take about one year to complete.
The research will include 16 adult participants who have been diagnosed with ET.
With files from the Canadian Press.