Phase III trial of Epidiolex (cannabidiol) for seizures associated with Lennox-Gastaut syndrome meets primary endpoint- GW Pharmaceuticals

GW Pharmaceuticals has announced positive results of the second randomized, double-blind, placebo-controlled Phase III clinical trial of Epidiolex (cannabidiol or CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. In this trial, Epidiolex, when added to the patient�s current treatment, achieved the primary endpoint for both dose levels with high statistical significance. During the treatment period, patients taking Epidiolex 20mg/kg/day achieved a median reduction in monthly drop seizures of 42 percent compared with a reduction of 17 percent in patients taking placebo, and patients taking Epidiolex 10mg/kg/day achieved a median reduction in monthly drop seizures of 37 percent compared with a reduction of 17 percent in patients taking placebo. Epidiolex was generally well tolerated in this trial. The pattern of adverse events was consistent with that reported in the previous two Phase 3 studies. One patient on 10mg/kg Epidiolex discontinued treatment due to an adverse event compared with six patients on 20mg/kg and one patient on placebo.

This trial follows the announcement in June 2016 of positive results in the first pivotal Phase III trial of Epidiolex for the treatment of seizures associated with LGS, and the March 2016 announcement of positive results in the treatment of seizures associated with Dravet syndrome. GW expects to submit a New Drug Application (NDA) to the FDA in the first half of 2017.