GW Pharmaceuticals’ Epidiolex drug reduces children’s seizures in phase III trial

The 120-patient trial demonstrated that patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39%, compared with a 13% reduction for those on a placebo, over a treatment period of 14 weeks.

Results from secondary efficacy endpoints reinforce the overall effectiveness observed with the drug, which was also identified to be well-tolerated in the study, the company noted.

The company is planning to use the data to file for approval of the drug with the US Food and Drug Administration, which has already granted orphan drug designation and fast track designation for the drug.

Epidiolex is a liquid formulation of pure plant-derived CBD, which is in development to treat several rare pediatric epilepsy disorders.

GW Pharmaceuticals CEO Justin Gover said: "The positive outcome of this Phase 3 trial is a significant milestone in the development of Epidiolex as a potential new treatment for patients suffering with Dravet syndrome.

"We are excited about the potential for Epidiolex to become the first FDA approved treatment option specifically for Dravet syndrome patients and their families."

A second pivotal trial in Dravet in ongoing apart from two phase studies in Lennox-Gastaut syndrome, another form of severe childhood epilepsy.

A trial for people with tuberous sclerosis complex is in the planning stages.

GW commercialized what is claimed to be the world’s first plant-derived cannabinoid prescription drug, Sativex, which is approved to treat spasticity due to various sclerosis in 28 countries outside the US.

Image: GW Pharmaceuticals is focused on discovering, developing and commercializing novel therapeutics from its cannabinoid product platform. Photo: courtesy of GW Pharmaceuticals.