GW Pharmaceuticals nears US new drug application for epilepsy drug

GW Pharmaceuticals said it planned to apply to market its cannabis-derived treatment for childhood-onset epilepsy early next year after the drug produced strong results from its late-stage clinical trail.

Epidiolex, the investigational cannabidiol medicine developed by GW, generated an average 42% reduction in monthly drop seizures when patients with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy, took a 20mg/kg/day dose.

The final-phase clinical trial for the treatment of seizures associated placebo produced a 17% reduction in monthly seizures, while patients taking 10mg/kg/day Epidiolex achieved a median reduction in monthly drop seizures of 37%.

This is the third positive Phase 3 trial for Epidiolex reported in 2016 and the second trial and second positive outcome in patients with Lennox-Gastaut syndrome.

Orrin Devinsky, principal investigator for the trial at the New York University Langone Medical Center's Comprehensive Epilepsy Center, said the second positive outcome "demonstrates the effectiveness of this product in this particularly difficult to treat, childhood-onset epilepsy".

He added: "The data from the Epidiolex Dravet and LGS studies offers the prospect of an FDA-approved CBD medicine that shows both clinically meaningful seizure reduction and a consistent safety and tolerability profile. I believe Epidiolex has the potential to become an important new option within the field of treatment-resistant epilepsy."

Justin Gover, GW's chief executive officer, said this latest trial also showed Epidiolex is likely to have an effective dose range, "allowing for dose flexibility to address individual patient needs".