In a first for the Canadian cannabis industry, the U.S. Drug Enforcement Administration has given Tilray Inc. approval to ship cannabis oil into the United States for medical research.
The Nanaimo, B.C.-based grower will send a blended THC and CBD study drug to the University of California San Diego’s Center for Medicinal Cannabis Research to be used in an early-stage clinical trial examining the neurological disorder essential tremor, the company announced Tuesday.
Like other large Canadian licensed producers, Tilray already ships cannabis to countries such as Germany and Australia for medical consumption and research. But getting cannabinoid products into the United States, even for clinical trials, has been hindered by strict border controls, an arduous registration process for study-drugs with the U.S. Food and Drug Administration (FDA), and a tightly-controlled supply of research-grade marijuana.
All domestic THC products used for research in the U.S. come from one government-run facility, and only one company, U.K.-based GW Pharmaceuticals Plc, has received approval to ship cannabinoid products, Epidiolex and Sativex, to the U.S. for research. Earlier this year, Epidiolex, a CBD-based treatment for a rare form of epilepsy, became the first cannabinoid medication to be fully approved by the FDA.
"It's exciting that we can show that a Canadian licensed producer can actually meet product quality standards for the FDA and get through the import process,” said Dr. Catherine Jacobson, Tilray’s director of clinical research.
Sending product south for an early-stage trial doesn’t mean Tilray will be supplying U.S. patients anytime soon. Even with positive results, it takes years of secondary and tertiary trials to get full FDA approval for a new drug.
That said, the data Tilray collects can inform drug development in other legal medical marijuana markets. And the company’s success navigating byzantine U.S. regulations is further indication that the marijuana conversation is changing south of the border.
Along with a broader shift in public opinion, driven by legalization in a number of states, improvements in cannabinoid extraction and product formulation is beginning to change the research landscape, said Dr. Jacobson, who was involved in getting Epidiolex registered as an Investigational New Drug with the FDA in 2014.
"For decades much of the clinical trial work was done on smoked cannabis… What's really shifted is the availability of study drugs that come in capsule form or oral solution, where the chemical composition is tightly controlled, and therefore dosing is tightly controlled,” she said.
Health Canada’s decision to regulate medical cannabis extracts such as oil under the Access to Cannabis for Medical Purposes Regulations (ACMPR) has significantly expanded the global availability of research-grade products, she added.
The essential tremor trial will be conducted by Dr. Fatta Nahab, a neurologist and director of the neuroimaging program at UC San Diego Health’s Movement Disorder Center. Dr. Nahab approached Tilray about acquiring a study-drug, after hearing anecdotal evidence from patients who used cannabis. It took more than a year to get approvals from the FDA and DEA, at a state and federal level, for the proposed trial, the lab and Tilray’s study drug formulation.
"Not only is it exciting to be working on a new drug that shows promise, but if this is a positive study, it’s going to provide all new avenues to understand mechanisms in the brain, to allow the development of next generation molecules that could be based on this particular molecule,” Dr. Nahab said.
From a business standpoint, essential tremor could prove an important indication, depending on the outcome of the trials. Around 5 per cent of U.S. adults over 65 suffer from essential tremor, said Dr. Nahab, but there are no drugs designed to treat the disorder, and the blood pressure and seizure medications sometimes used have considerable negative side effects. The condition causes involuntary shaking, most often in the hands, primarily in people over the age of 40.
By focusing on a new indication, Tilray has more scope for intellectual property development, a key component of commercialization.
“We talk a lot about pain, chemotherapy induced nausea and vomiting, there’s a lot about epilepsy, but this is a neurological condition, a movement disorder that has not really been looked at before,” Dr. Jacobson said.