On March 14, 2016, GW Pharmaceuticals (NASDAQ: GWPH), a biopharma company with two promising cannabis-based medications, announced positive results for the first pivotal Phase 3 study of Epidiolex, a CBD-based medicine, in treating Dravet syndrome, a severe form of pediatric epilepsy.
GW Pharmaceutical’s Phase 3 study involved 120 patients and added to each patient’s current anti-epileptic drug treatment regimen, with 61 patients receiving 20mg/kg/day of Epidiolex and 59 patients receiving the placebo.
On average, the patients treated with Epidiolex saw a 39% reduction in monthly convulsive seizures, compared to a 13 percent reduction for those patients treated with the placebo, which is considered highly statistically significant.
GW is recruiting 150 patients to participate in the second Phase 3 study of Epidiolex in treating Dravet syndrome.
According to Justin Gover, GW’s Chief Executive Officer, “The positive outcome of this Phase 3 trial is a significant milestone in the development of Epidiolex as a potential new treatment for patients suffering from Dravet syndrome. We are excited about the potential for Epidiolex to become the first FDA approved treatment option specifically for Dravet syndrome patients and their families.”
The FDA previously awarded Epidiolex Orphan Drug Designation and Fast Track Designation in treating Dravet syndrome, a severe form of pediatric epilepsy for which there are currently no FDA-approved treatment options.
By mid-day, GWPH’s announcement made the stock soar 135.54%, hitting $90.59, as of 1:02 p.m. EST.
On CNBC this morning, Jim Cramer championed GW Pharmaceutical’s announcement and the stock soaring.