People with a rare and more severe form of epilepsy called Dravet syndrome experienced significant decrease in seizures after taking cannabis-based drug Epidiolex.
In 2018, the U.S. Food and Drug Administration approved Epidiolex for the treatment of Dravet and Lennox-Gastaut syndromes in children above age 2. It is the first time that the agency approved a drug made from purified marijuana substance as well as the first treatment for Dravet syndrome.
Results of the phase 3 clinical trial showed that a lower dose of 10 milligrams per kilogram of body weight taken daily has the same efficacy as the 20-milligram dose. The only difference of the new trial from the 2017 paper published in the New England Journal of Medicine is the dosing.
A total of 199 children with Dravet syndrome took the drug infused with cannabidiol, a non-psychoactive compound found in cannabis. Within 14 weeks, the 20-milligram group had 47 percent fewer seizures and 46 percent fewer seizures with convulsions.
The group with only 10 milligrams of Epidiolex had 56 percent fewer seizures and 49 percent fewer seizures with convulsions. Seizure frequency in the placebo group decreased by 30 percent, while seizures with convulsions dropped by 27 percent.
“I personally was surprised to see such a robust treatment effect of the lower dose,” said co-author Dr. Ian Miller of Nicklaus Children’s Hospital in Miami, Florida. “Side effects are less frequent at the lower dose, and