A powerful drug derived from marijuana is on the cusp of federal approval
Published on May 24, 2017
While whole-plant cannabis remains federally illegal, GW pharmaceuticals is working to gain FDA approval for a cannabis based drug, Epidiolex. Derived from cannabidiol (CBD), the drug contains no THC, the compound in marijuana that gets the user high. GW Pharma has now released two studies for Epidiolex targeting specific types of epilepsy, Lennox-Gastaut Syndrome and Dravet Syndrome. Both studies showed great promise in reducing seizures in patients by over 40% with some patients even having their seizures halted entirely. The success of these studies allows GW pharma to apply for a streamlined approval process and if approved, Epidiolex would become the first FDA approved drug containing cannabidiol.
Because drugmaker GW Pharma was able to show that the product addresses a critical need, it was able to apply for a designation that could speed up the approval process. The company still faces some hurdles, though — the FDA has not yet approved any applications to sell marijuana for a health condition, and hasn't given the green light to any drugs containing cannabidiol.
The second trial, the results of which were published this week in the New England Journal of Medicine, looked at 120 children with Dravet syndrome. Half were given the drug and half received a placebo. Forty-three percent of participants given the drug saw their seizures reduced by half, and 5% stopped having seizures entirely. By comparison, the seizure rate in the group given a placebo barely budged.