At the 70th annual meeting of the American Epilepsy Society in Houston this week, GW Pharmaceuticals announced results of the first ever randomized, double-blind, placebo-controlled studies of CBD. The company’s proprietary CBD drug is called Epidiolex.
In the Dravet syndrome study, 43 percent of patients taking Epidiolex had a greater than or equal to 50 percent reduction in convulsive seizures compared to 27 percent of patients taking placebo. Seven patients taking Epidiolex achieved total seizure freedom. Click here to see data.
In the Lennox Gastaut syndrome study, 44.2 percent of Epidiolex patients had a greater than or equal to 50 percent reduction in drop seizures compared to 23.5 percent of patients taking placebo. Click here to see data.
“These placebo-controlled studies demonstrate that Epidiolex provides clinically meaningful reductions in seizure frequency together with an acceptable safety and tolerability profile,” stated Orrin Devinsky, MD, of New York University Langone Medical Center’s Comprehensive Epilepsy Center and Principal Investigator of the Dravet syndrome trial. “My colleagues and I are excited at the future prospect of prescribing an appropriately standardized and tested pharmaceutical formulation of cannabidiol.”
Posters presenting the data note that findings reported in these studies are specific to GW Pharmaceuticals’ formulation of cannabidiol and cannot be extrapolated to other CBD products.
As the chart above illustrates, having completed clinical trials with more than 1,500 patients, including expanded access trials for more than 1,000, GW plans to seek a New Drug Application (NDA) for FDA approval in a few months. If approved, GW will market Epidiolex under a new company name in the US: Greenwich Biosciences.