GW Pharmaceuticals Files for FDA Approval After Report Confirms Success in Treating Epilepsy

GW Pharmaceuticals has chosen the perfect moment to file its cannabis-derived therapy, Epidiolex, with U.S. regulators.

The New England Journal of Medicine just published results from a Phase III study showing that GW’s Epidiolex (derived from cannabidiol) significantly reduced monthly convulsive seizures, especially in children with Dravet syndrome, one of the most difficult types of epilepsy to treat. Children can have dozens, even hundreds, of seizures per month.

GW Pharmaceuticals first reported in March 2016 that CBD-derived Epidiolex cut monthly convulsive seizures by 39 percent in children with Dravet syndrome, but full results of the 120-patient study were only published last week.

The findings stem from a double-blind, placebo-controlled study—the most scientifically rigorous type of investigation possible.

“This study clearly establishes cannabidiol as an effective anti-seizure drug for this disorder and this age group,” said principal investigator and lead author of the study, Dr. Orrin Devinsky, director of the Comprehensive Epilepsy Center at New York University Langone Medical Center.

“It certainly deserves to be studied in other types of epilepsy,” he added.

The journal article also showed that five percent of patients stopped having seizures altogether and 43 percent saw their seizures cut by half.

The treatment, which is given as a syrup, is a purified form of cannabidiol (CBD) and contains less than 0.1 percent of tetrahydrocannabinol (THC).

GW is seeking regulatory approval to sell Epidiolex as a treatment for both Dravet and Lennox-Gastaut syndrome, another severe form of epilepsy.

Stephen Wright, GW’s chief medical officer, said the company would submit its application to the Food and Drug Administration by mid-year, with a filing in Europe following a little later in 2017.

An editorial in the New England Journal of Medicine said the clinical trial represented “the beginning of solid evidence for the use of cannibinoids in epilepsy,” after an era of anecdote and emotional debates.

“These results suggest that Epidiolex can provide clinically meaningful benefits, and I look forward to the prospect of an appropriately standardized and tested pharmaceutical formulation of cannabidiol available as a treatment option for these patients,” said Devinsky.