The U.K.-based GW Pharmaceuticals (NASDAQ: GWPH) currently has its lead drug, Epidiolex, under review by the U.S. Food and Drug Administration (FDA). Epidiolex, which is a CBD-based compound designed to treat two rare types of childhood-onset epilepsy – Dravet syndrome and Lennox-Gastaut syndrome – easily met its primary endpoint in two separate phase 3 trials for each indication (four total late-stage trials). In fact, in one of the Dravet syndrome studies, Epidiolex tripled the reduction in seizure frequency from baseline relative to the placebo (39% vs. 13%).
As the icing on the cake, this past week the FDA’s review panel unanimously voted in favor of recommending the drug for approval. The FDA isn’t required to follow the recommendation of its panel, but it often does. If approved, GW Pharmaceuticals will be the first drugmaker to get the green light from the FDA for a cannabinoid-based drug. This approval may have the potential to open the eyes of lawmakers who’ve held medical cannabis, or cannabinoids, back. It may even result in a rescheduling of CBD at the federal level.