GW Pharmaceuticals Announces Positive Phase 3 Pitotal Study Results for Epidiolex (cannabidiol)
Published on Mar 16, 2016
In a phase 3 trial conducted by GW Pharmaceuticals it was found that patients with Dravet syndrome (a serious type of epilepsy in children) greatly benefited from the drug, epidiolex, which is created from cannabis. As the first placebo controlled study using the drug, the resulting drop in seizures is so significant that experts expect the drug to be available by prescription in the future. The average age for patients involved in the study was ten years old, with one third under the age of 6. Patients taking epidiolex showed a median decrease in seizures of 39%. GW plans to do another phase 3 trial in the future with 150 patients.
“The results of this Epidiolex pivotal trial are important and exciting as they represent the first placebo-controlled evidence to support the safety and efficacy of pharmaceutical cannabidiol in children with Dravet syndrome, one of the most severe and difficult-to-treat types of epilepsy,” said Orrin Devinsky, M.D., of New York University Langone Medical Center’s Comprehensive Epilepsy Center. “These data demonstrate that Epidiolex delivers clinically important reductions in seizure frequency together with an acceptable safety and tolerability profile, providing the epilepsy community with the prospect of an appropriately standardized and tested pharmaceutical formulation of cannabidiol being made available by prescription in the future.”