Research conducted at the Hospital for Sick Children (SickKids) establishes promising safety and tolerability data for Tilray 2:100 oil for children with drug-resistant epilepsy (DRE) due to Dravet Syndrome
NANAIMO, BRITISH COLUMBIA – Tilray Inc., a global pioneer in medical cannabis production and distribution, is pleased to announce that a study featuring Tilray 2:100, a medical cannabis oil containing high amounts of cannabidiol (CBD) and conservative amounts of tetrahydrocannabinol (THC), has shown promising results for children with drug-resistant epilepsy (DRE) due to Dravet Syndrome. The findings of the Phase II trial, which was designed and conducted by researchers at the Hospital for Sick Children in Toronto (SickKids), were published today [insert link to article] in the peer-reviewed medical journal Annals of Neurology.
“We are excited by the encouraging results of this study and the ability to already be offering this highly concentrated CBD product to patients in Canada. We developed this product around a strong existing evidence base that CBD may have numerous beneficial uses,” said Catherine Jacobson, Director of Tilray’s Clinical Research Program.
Tilray 2:100 contains the highest concentration of cannabis-extracted CBD in a medical cannabis product available through Canada’s Access to Cannabis for Medical Purposes Regulations (ACMPR). Tilray 2:100 has a target concentration of 2mg/ml THC and 100mg/ml CBD for a total cannabinoid amount of 80mg THC and 4,000mg CBD in each 40ml bottle.
Tilray is making Tilray 2:100 available first to pediatric patients through the ACMPR. As supply increases, the product will be made available to additional patients in need. To help support access to this product, Tilray is proud to announce a discounted introductory price, as well as a compassionate pricing program based on financial need. For information on Tilray 2:100 and the compassionate pricing program, please call Tilray’s Patient Services team at 1-844-TILRAY1.
In a press release issued by SickKids, Dr. Blathnaid McCoy, Staff Neurologist at SickKids who conducted the study and authored the research, said: “Our study adds to a growing body of evidence that cannabinoids can exert anti-seizure effects and are safe and tolerable in treating paediatric DRE.”
Dr. McCoy continued, “In the participants who reached the target treatment dose we saw a statistically significant reduction in motor seizures, and an increase in seizure-free days compared to those who did not reach the target dose. We observed promising clinically beneficial effect’s including a reduction in seizure frequency and improvements in certain aspects of adaptive functioning and quality of life measures.”
As the first study of its kind to examine with rigor the dosing and tolerability of a mixed cannabinoid product containing both CBD and THC in children with DRE due to Dravet Syndrome, these results set the foundation for further work to advance successful treatment and outcomes for this population of children who until now, had little hope for better health outcomes.
A limitation in this study concerns the small number of participants, the majority of whom were already taking a prescribed antiepileptic drug. Tilray donated product for the trial and funded the research. Next steps include additional research with more participants and variable doses of combined THC/CBD.
Tilray is a global pioneer in the research, cultivation, production and distribution of medical cannabis and cannabinoids currently serving tens of thousands of patients in ten countries spanning five continents.
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