Tilray, a Canadian cannabis company, has received permission from the U.S. Drug Enforcement Agency to export a medical marijuana drug to the United States for a clinical trial, the company announced Tuesday. The medication will be studied at the University of California San Diego to determine its usefulness treating essential tremor, a neurological disorder affecting millions of Americans.
Dr. Fatta Nahab, a neurologist and associate professor of neurosciences at the UCSD medical school, said receiving approval to import the drug from the Food and Drug Administration and DEA took months.
THC and CBD
The drug Tilray will export is a capsule with a formulation containing both THC and CBD. The medication will be studied at the UCSD Center for Medicinal Cannabis Research for its effect on essential tremor, a neurological disorder that causes involuntary movements of the body.
“This is an oral capsule formulation that has actual plant in it,” Nahab said. “It’s a purified, medical-grade formulation, and to my knowledge, that’s never been imported from Canada before.”
Nahab said that the quality of the medicine, which is derived directly from cannabis plants, makes it a good candidate for clinical research.
“We’ve got a set dosing, fixed, highly consistent, and so it’s really going to help us advance the field much more,” said Nahab.
Dr. Catherine Jacobson, Tilray’s director of clinical research in California, said importing a cannabis drug is an important milestone in furthering study into the medicinal applications of the plant.
“It’s quite significant,” she said.
Nahab said in a press release that researchers hoped their work would garner data needed to set parameters for the use of medical cannabis.
“It’s exciting to advance our work in this area by conducting a first-of-its kind trial of purified medicinal cannabis for a common neurological disorder like essential tremor,” said Nahab. “Until now patients have been on their own to figure out the efficacy, safety, and dosing of cannabinoids. This trial should help answer many of these critical questions.”
‘No Good Treatment’ for Neurological Disorder
Jacobson said that researchers thus far have been unable to find a medication that successfully controls involuntary body movement.
“There is no good treatment for essential tremor,” Jacobson said. “The ultimate goal, what we want to know, is we want to understand whether cannabinoids might be a good treatment.”
Jacobson added that there is “good scientific rationale” to study cannabis as a treatment for essential tremor because of strong anecdotal evidence of its effectiveness at improving the quality of life for patients.
The clinical study of 16 adult patients diagnosed with essential tremor will begin in 2019 and is expected to last one year. The clinical trial is supported by Tilray and the International Essential Tremor Foundation and is part of a larger effort to determine “how to target therapies for specific symptoms,” Jacobson said.
Tilray Stock Jumps
After the announcement that the company had received permission to export the drug to the United State, shares in Tilray, based in Nanaimo, B.C., were up sharply in trading on Tuesday. The company’s stock, which only began trading after an IPO at $17 per share in July, was hovering around $150 Tuesday afternoon, up nearly 25 percent from the previous day.