In the U.S., GW Pharmacuticals’ Epidiolex is the only CBD product to receive Food and Drug Administration (FDA) approval for any use. This summer, the agency rejected Charlotte’s Web’s application to approve CBD as a dietary ingredient.
Currently, Epidiolex is prescribed as a treatment for Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex. However, other companies seek government sign-offs to approve CBD and other cannabis-based treatments for epileptic conditions in children and adults. While companies haven’t had the same level of success with U.S. regulatory approval as GW Pharma, global companies have reported promising results regarding scientific research, other governmental approvals and physician prescriptions in other countries. (GW Pharma’s parent company, Jazz Pharmaceuticals, did not respond to Hemp Grower’s request for comment for this story.)
One company diving into cannabis-based epilepsy treatments is Toronto-based Avicanna. In September, the company announced it had filed a U.S. patent application for epilepsy treatment methods using cannabinoid formulations titled, “Methods for Reducing or Eliminating Incidence of Seizures and Sudden Unexpected Death in Epilepsy.”
Last month, Hemp Grower spoke with Dr. Karolina Urban, Ph.D., Avicanna’s vice president of scientific and medical affairs, about the company’s ongoing work addressing cannabis-based treatments for epilepsy.
While Urban could not share which cannabinoids were used in the treatment methods for which the company has filed the patent, she said, “it is a specific ratio of various cannabinoids and terpenes.”
Avicanna grows cannabis in the foothills of Colombia’s Sierra Nevada de Santa Marta mountain range, sells cannabis products in Canada’s medical and adult-use markets, and licenses hemp-based CBD topical formulations to companies re+PLAY and Red White & Bloom to sell in the U.S.
For its various cannabis products in Canada’s medicinal market, the company conducts observational studies that yield results about absorption rates and bioavailability for various product types, as well as which cannabinoid ratios work best for which conditions; then, it shares that information with physicians so they can make accurate recommendations to patients.
However, some products are subjected to a longer, more rigorous pharmaceutical process, and that’s what the company seeks for the new epilepsy formulations. The products will undergo more preclinical studies, then may receive regulatory review by the FDA or Health Canada, Urban said.
Avicanna’s epilepsy drug formulations have been investigated by Dr. Peter Carlen, M.D., an epilepsy researcher at the University Health Network’s (UHN) Krembil Research Institute in Toronto.
A press release from Avicanna stated the following about Carlen’s research: “Preliminary electrophysiological studies on seizure induced wildtype mouse cortical slices determined that treatment with the Formulation Candidate produced significant anti-convulsant effects as compared to treatment with cannabidiol (‘CBD’) or tetrahydrocannabinol (‘THC’) alone.”
When cannabis-based treatments are used for epilepsy, Urban said, they target various receptors, whereas many anti-epileptic drugs currently on the market target single receptors and are sometimes prescribed in combination with other drugs that do the same thing. These pharmaceutical drugs can have numerous side effects, Urban said, adding that between 30% and 40% of people with epilepsy don’t benefit from taking them.
Refractory, or drug-resistant, epilepsy eventually affects about one-third of people with