Leaders at the Epilepsy Foundation recently applauded the positive results of the phase-three clinical trial of Epidiolex, which GW Pharmaceuticals has designed to treat Lennox-Gastaut Syndrome (LGS).
The randomized, double-blind, placebo-controlled trial demonstrates that Epidiolex decreases the drop seizures that are common in LGS, a rare and serious kind of childhood-onset epilepsy.
“This study, which provides further controlled clinical evidence of beneficial effects of cannabidiol in a severe epilepsy syndrome, also underscores the need to better understand the biological mechanisms responsible,” Dr. Brandy Fureman, Epilepsy Foundation vice president of research and new therapies, said. “To help spur more research in this area, the foundation offers a targeted grant program to support research on cannabinoids and epilepsy.”
During the trial, Epidiolex was combined with the patient’s current treatment. With this approach, the therapy was associated with a significant decline in the monthly frequency of the patient’s drop seizures. This outcome continued through the 14-week trial period, which compared Epidiolex to the placebo.
“We are delighted to announce positive results in this phase-three trial of Epidiolex in patients with Lennox-Gastaut syndrome, and particularly pleased that this result is consistent with our recent phase-three pivotal data for Epidiolex in Dravet syndrome,” GW CEO Justin Gover said. “We believe that this result further demonstrates that Epidiolex offers the potential to be a new effective therapy within the field of treatment-resistant childhood-onset epilepsies. We now look forward to advancing Epidiolex towards the submission of an NDA with the FDA in the first half of 2017.”
