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 epilepsy, according to Johns Hopkins Medicine, which is one reason why cannabis companies are working to develop their own treatments.

“We still need to understand better, specifically on what these cannabinoids and terpenes are doing,” Urban said. “However, we know that CBD or THC or other cannabinoids are not one receptor-specific, and they have all these other roles. And that could be why they’re having the effect. So, we still need to do research on it to justify the hypothesis, but you do see it across the industry, that people are looking at it.”

Aside from utilizing cannabis’ natural receptor-binding capabilities and creating an entourage effect vis-a-vis the plant’s various compounds, another way Urban said Avicanna plans to further improve its epilepsy drug is by offering the most acute and effective treatment possible. Certain ingredients can improve a product’s shelf life and maximize absorption rates in patients, she added.

“So, part of that patent is also the work that we’ve done around it to increase the bioavailability and absorption of these cannabinoids,” Urban said.

Photo courtesy of MGC Pharmaceuticals

All of MGC Pharmaceuticals’ cannabis-based products are sourced from growers, with whom the company shares genetics and knowledge.

Developments Across the World

MGC Pharmaceuticals is another company in the epilepsy-treatment space. The global pharmaceutical company’s head office is in Perth, Australia, its European operational headquarters is in Ljubljana, Slovenia, and its European corporate headquarters is in London.

In October, Hemp Grower spoke with Roby Zomer, co-founder, managing director and CEO at MGC Pharma, about the company’s cannabis-based epilepsy treatments.

Rather than synthetic sources, all of the company’s cannabis-based products are sourced from growers, with whom it shares genetics and knowledge, Zomer said. Several years ago, the business grew its own cannabis but now sources out the active pharmaceutical ingredients to minimize risks and costs associated with variable climate conditions and other factors.

MGC Pharma created an epilepsy treatment with a 1-to-20 THC-CBD ratio—100 milliliters of CBD and 5 milliliters of THC—called CannEpil, that physicians prescribe to patients in Australia, the United Kingdom and Ireland, Zomer said. The drug also includes three minor cannabinoids, he said, but he added that he could not yet disclose what those are.

Earlier this year, CannEpil was added to the Primary Care Reimbursement Service as part of Ireland’s Medical Cannabis Access Programme (MCAP), allowing Ireland’s Health Service Executive (HSE) to cover patient insurance costs for the drug.

Looking forward, Zomer said MGC Pharma plans to work toward achieving health insurance coverage for CannEpil in other countries.

The company has been able to keep prices affordable for drugs under these “cannabis-access schemes” before insurance, Zomer said. (In Ireland, for example, the company charges between 7,000 to 8,000 Euros—roughly $7,958 to $9,096 USD—per year, while some other companies charge three to four times that much.)

“I see all the time—there is … news about companies that have a good drug, but then they increase the price of it and it’s falling on the patient …. It’s something that I don’t want to see in the patients that are being treated with MGC products,” Zomer said. “For me, it’s [my] personal [view] that I don’t want our drug to be considered as a burden on the families and the people that need it.”

MGC Pharma is also creating an ionic-liquid form of CannEpil that Zomer said “will remove the need of oil-based treatment.” He added that the drug is in a nanoparticle form, “increasing the bioavailability and reducing the blood-to-brain barrier” compared to oil-based drugs.

The company includes minor cannabinoids and terpenes in these products, but Zomer said he could not yet disclose what those are.

Two other cannabis-based products that MGC Pharma has manufactured to treat epilepsy are MP 100 and MP 130, which Zomer said contain CBD isolate and CBD with low levels of THC, respectively.

MGC Pharma has worked on epilepsy-treatment development with scientific advisers Dr. Uri Kramer, M.D., former director of the Pediatric Epilepsy Service at Tel Aviv Sourasky Medical Center in Israel, and Dr. David Neubauer, M.D., Ph.D., head of the Department of Child, Adolescent and Developmental Neurology at University Children’s Hospital in Ljubljana.

Both researchers had investigated epilepsy treatments prior to linking up with MGC Pharma. “They did not know each other … the whole time, and when both of them joined our board committee, we were able to compare their results and to try to build the formula afterwards,” Zomer said.

MGC Pharma now has plans to expand its footprint in the U.S. In early October, the company announced that it is entering into a three-year, $24-million contract with AMC Holdings to conduct clinical studies for ultimate FDA approval. Zomer added that the contract encompasses cannabis-based products such as CannEpil.

“So, the U.S.—it’s become a real-life target for MGC,” Zomer said. “And we will proceed and move forward—same as in the U.K., Ireland, Australia, Brazil, Russia.”

 

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