Tilray shares update on pediatric epilepsy clinical trial

You might have heard about the clinical trial Tilray is supporting at the Hospital for Sick Children (SickKids) in Toronto. The trial is studying how children with Dravet Syndrome, a rare and debilitating form of epilepsy, respond to adjunct therapy with a high-CBD medical cannabis extract that Tilray developed for the trial.

Although the trial is still progressing, we are tremendously encouraged to hear that there are patients in the trial who are responding positively to the product. Children suffering from intractable forms of epilepsy are a vulnerable patient population. We supported this trial because we know that medical cannabis products have been used to treat seizures and wanted to learn more about how we could help these young patients. Clinical research is a critical step to uncovering effective ways to alleviate the seizure burden in this population of children with a rare, difficult-to-treat disease. More research can help patients avoid the “trial and error” approach to product selection by giving patients and their doctors more reliable information about dosing and side effects. It’s also an important first step towards obtaining insurance reimbursement.

Currently, the study drug used in the clinical trial is only authorized for use by patients participating in the trial. Tilray is awaiting authorization from Health Canada to offer a similar product through the ACMPR. This product will contain the same target THC and CBD concentration as the study drug – specifically, 2 mg/mL THC and 100 mg/mL CBD, which amounts to 80 mg THC and 4,000 mg CBD in each 40 mL bottle. Once authorized for sale, this would be the highest concentration of cannabis-derived CBD found in a medical cannabis product legally available to Canadian patients. After the product is authorized for distribution through ACMPR, Tilray will first make it available to patients who participated in the trial. As we are able to increase supply, we hope to make it available to patients outside of the trial.

Due to the amount of CBD in the product, it is costly to produce. To help support access to this product, Tilray is proud to announce a compassionate pricing program to ensure participants in the trial and other children with Dravet Syndrome can access our 2:100 oil. Patients with Dravet Syndrome who qualify for compassionate pricing will be able to purchase our 2:100 oil at a reduced price of up to 60% off the retail cost, depending on financial need.

Tilray has been a strong advocate for insurance coverage of medical cannabis products, and we will continue to advocate for insurance coverage for all of our patients. It is our hope that this trial, if it demonstrates the effects of a specific medical cannabis product for a patient population with high need, will enhance our efforts to help patients get the insurance coverage they so desperately need to make medical cannabis products more accessible to them and their families. We also urge patients to contact their insurance providers to let them know why medical cannabis coverage is so important.

We will continue to update patients on the availability of our 2:100 oil as we move through the regulatory process. For information on the 2:100 compassionate pricing program, please call our Patient Services team at 1-844-TILRAY1.