GW Pharmaceuticals issued a press release announcing important clinical news. They recently completed a study of adjunctive Epidiolex (cannabidiol) in the treatment of drop seizures in patients with Lennox Gastaut syndrome (GWEP1423). The press release is available in the following link for your awareness: GW – LGS1 Press Release – FINAL
The study randomized 171 patients, with 86 in the 20 mg/kg CBD treatment group and 85 in the placebo group. The primary efficacy endpoint of the study was the comparison between the reduction in monthly drop seizures across the entire treatment period, including the initial dose escalation. In the CBD group, the median drop seizure frequency reduction was 44%, compared with 22% in the placebo group (p=0.0135). A series of secondary endpoints also reinforced the overall effectiveness observed with CBD.
From the safety point of view, CBD was reasonably well tolerated, with no unexpected new adverse events emerging. More details can be found in the release link posted in the first paragraph.
These results, coming on top of the positive results that we previously reported in a study of CBD in Dravet syndrome add to the body of evidence from placebo-controlled clinical studies to support our efforts to submit an NDA for regulatory approval, and the continued development of Epidiolex in treatment-resistant epilepsies.
We look forward to working with FDA during the course of this year in the hope that we can obtain approval and make Epidiolex available as a prescription medicine in the future.
Thank you so much for your continuing interest in our research.