Nearly a year ago, UK drug manufacturer GW Pharmaceuticals filed its breakthrough epilepsy treatment for approval by U.S. regulators. The drug, Epidiolex, is derived from cannabidiol, or CBD, a non-psychoactive constituent of the cannabis plant. And on Tuesday, the FDA issued a report citing the “substantial evidence” GW Pharma had provided on the drug’s effectiveness. Could Epidiolex be the first cannabis-based drug to get FDA Approval?
Epidiolex: The Cannabis-Based Drug That Can Beat Epilepsy
There are many different types of epilepsy. But Dravet syndrome and Lennox-Gastaut syndrome are two of the severest forms of the disease. They’re also two of the hardest to treat.
Dravet and Lennox-Gastaut particularly impact children, who can suffer dozens and sometimes hundreds of seizures each month. Upwards of 20 percent of children with Dravet syndrome die before they reach adulthood.
Yet cannabidiol (CBD), the plant cannabinoid linked to many of the therapeutic effects of cannabis, has shown promise as an anti-seizure medication.
The fact that CBD is non-psychoactive and doesn’t get users “high” makes it especially well-suited as a cannabis treatment for children. And GW Pharmaceuticals has formulated Epidiolex with this age group in mind.
Epidiolex is essentially a purified form of CBD. The CBD content comes from a strain of marijuana bred to produce high concentrations of cannabidiol. And in a double-blind, placebo-controlled study, the drug did remarkably well.
In March 2016, GW Pharma published the results of the first phase of its study. Researchers found that Epidiolex cut monthly seizures by 39 percent in children with Dravet syndrome.
But it wasn’t until May of last year that full results from the 120-patient study appeared in The New England Journal of