GW Pharmaceuticals has announced positive results from the first of two Phase 3 studies of Epidiolex® (cannabidiol or CBD) in the treatment of Dravet syndrome. Median seizure reduction was 39% with Epidiolex versus only 13% with placebo, a scientifically significant finding. In addition, the side-effect profile was acceptable for an anti-epileptic drug and secondary endpoints were supportive of a robust treatment effect.
“This is a very important day for the epilepsy community and families struggling with Dravet and other devastating epilepsies,” said Dr. Jacqueline French, chief scientific officer for the Epilepsy Foundation. “Although anecdotal evidence supported an effect of CBD in serious childhood epilepsies, this is the first scientific evidence that confirms this effect.”
Since 2014, the Epilepsy Foundation has called for an end to Drug Enforcement Administration (DEA) restrictions that limit clinical trials and research into medical marijuana for epilepsy. Learn more.
In referring to the recent study results, Dr. French added, “This data should support eliminating barriers to CBD research. GW Pharmaceuticals is leading the development of an FDA pipeline for CBD and this represents a significant step forward.”
“The Epilepsy Foundation is thrilled to see positive results in this first controlled clinical study of GW Pharmaceuticals’ Epidiolex in children living with Dravet syndrome,” said Warren Lammert, a founder of the Epilepsy Therapy Project of the Epilepsy Foundation. “We are proud to have contributed a small grant to support the early trials of Epidiolex, and we continue to advocate on behalf of those individuals and families with uncontrolled seizures and their doctors for the ability to participate in clinical trials and to access cannabis therapies.”
Epidiolex has both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA) in the treatment of Dravet syndrome, a rare and debilitating type of epilepsy for which there are currently no treatments approved in the U.S. GW Pharmaceuticals is also pursuing two Phase 3 trials in Lennox-Gastaut syndrome and the second pivotal trial in Dravet syndrome.”
“One third of those living with epilepsy suffer uncontrolled seizures and many live with unacceptable side effects from existing therapies,” said Mr. Lammert. “This success underscores the importance of our mission and focus on advancing new therapies to eliminate seizures and mortality from epilepsy.“