Cannabis-Based Drug Lowers Epileptic Seizures In Children
Children afflicted with Dravet Syndrome, a rare form of epilepsy, have been effectively treated with a cannabis-based drug, Epidiolex, containing cannabinoids, the GW Pharmaceuticals announced Monday.
Earlier, this kind of disease did not have any approved treatments. The Phase III stage of the study revealed that active ingredients from marijuana brought down the epileptic seizures in Dravet syndrome patients.
Studying 120 patients aged below 10 years, 36 of whom were younger than six, experts gave the participants 20 mg of Epidiolex everyday, while the other 59 took a placebo drug apart from the anti-epileptic drug (AED) regimen taken at present. About 13 seizures per month was the median baseline.
After a fortnight, it was found that the monthly frequency of convulsives came down by a median of 39 percent, contrasted with the placebo group, whose baseline reduction was only 13 percent.
"This shows that cannabinoids can produce compelling and clinical important data and represent a highly promising new class of medications, hopefully in a range of conditions," Chief Executive Officer Justin Gover said.
GW is planning to have a meeting with the U.S. Food and Drug Administration (FDA) in order to get Epidiolex out on the market.
"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 Devinsk from the 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."
Some side effects of the drug tended to induce "reduced appetite, vomiting, diarrhea, fatigue, fever, drowsiness/sleepiness, upper respiratory tract infections and convulsion."
"It clearly provides us with an excellent basis to be confident about the outcome of the additional trials because this trial has shown that the previous open-label data was very predictive," Gover said.