GW Pharmaceuticals said the drug, Epidiolex, was able to successfully reduce the number of convulsive seizures in patients, compared to those taking a placebo. The results more than doubled the value of the company’s stock.
If the drug is approved, it will be the first cannabis extract based prescription medication in the United States.
The trial focused on treating children with Dravet syndrome, a rare form of severe epilepsy that often appears within the first year of an infant’s life and can cause cognitive impairment, behavioural disorders and motor issues.
The study looked at 120 patients, the average age of which was 10-years-old, who had around 13 convulsive seizures a month. The study found that those patients given 20mg of Epidiolex a day saw a reduction in monthly seizures by about 39 per cent.
New York University Comprehensive Epilepsy Center director Dr. Orrin Devinsky said the results give hope to patients with Dravet syndrome that a prescription may be available in the future.
“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 Devinsky.
GW Pharmaceuticals CEO Justin Gover said, in light of the results, the company will request a meeting with the FDA to discuss Epidiolex regulation.
“Dravet syndrome is one of the most catastrophic types of epilepsy in children and safe and effective treatments are desperately needed,”said Dravet Syndrome Foundation executive director Mary Anne Meskis. “We are thrilled to learn of these positive results, which bring much needed hope to the children and families who have been living with these debilitating seizures.”
Results are also expected this year for a similar Epidiolex trial being used in treatment of Lennox-Gastaut syndrome, another rare form of epilepsy.