Phase III GWPCARE2 trial of Epidiolex in Dravet Syndrome published in JAMA Neurology.- GW Pharma

GW Pharmaceuticals announced that JAMA Neurology has published results from the second positive Phase III trial (GWPCARE2) of Epidiolex (cannabidiol) oral solution CV in children with seizures associated with Dravet syndrome. The article has been published online and will be included in the May 2020 print issue of the journal. Epidiolex, a pharmaceutical formulation of highly purified cannabidiol (CBD), is the first prescription, plant-derived cannabis-based medicine approved by the FDA for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. In the study, two doses of Epidiolex, 10 and 20 mg/kg/day, significantly reduced convulsive seizure frequency compared to placebo in children two to 18 years of age with highly treatment-resistant Dravet syndrome, meeting the study’s primary endpoint. The primary endpoint outcomes for the 10 and 20 mg/kg/day arms were similar, with seizure reductions of 49% and 46% from baseline, respectively, vs 27% for placebo (10 mg/kg/day, p=0.0095 and 20 mg/kg/day, p=0.0299). See: "Dose-Ranging Effect of Adjunctive Oral Cannabidiol vs Placebo on Convulsive Seizure Frequency in Dravet SyndromeA Randomized Clinical Trial" Ian Miller et al. JAMA Neurol. Published online March 2, 2020. doi:10.1001/jamaneurol.2020.0073