GW Pharmaceuticals announced positive data from the second randomized, double-blind, placebo-controlled Phase 3 trial of Epidiolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS).
The trial (n=225) included patients with a confirmed diagnosis of drug-resistant LGS currently uncontrolled on one or more antiepileptic drugs. The data showed Epidiolex added to the patient’s current treatment met the primary endpoint for both doses with high statistical significance. Patients who took Epidiolex 20mg/kg/day had a median reduction in monthly drop seizures of 42% vs. 17% in patients taking placebo (P=0.0047). Also, patients taking Epidiolex 10mg/kg/day had a median reduction in monthly drop seizures of 37% vs. 17% in patients taking placebo (P=0.0016).
Sensitivity analyses of the primary endpoint for both dose groups confirmed the robustness of these results. The study also reported Epidiolex was generally well tolerated.
These findings follow pivotal data from the first Phase 3 trial in June 2016, and the positive results for the treatment of seizures associated with Dravet syndrome in March 2016.
Epidiolex is an oral formulation of cannabidiol under investigation for various rare childhood-onset epileptic disorders. GW Pharmaceuticals anticipates a New Drug Application (NDA) submission to the Food and Drug Administration (FDA) in the first half of 2017.
For more information call (760) 795-2200 or visit GWpharma.com.