Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.GW Pharmaceuticals has started a phase 3 clinical trial of Epidiolex (cannabidiol or CBD) as an adjunctive therapy to treat seizures associated with Tuberous Sclerosis Complex (TSC).
Subscribe to our email newsletter
TSC is a rare genetic condition characterized by formation of non-malignant tumors in several organs.
The 16-week dose-ranging trial will evaluate Epidiolex against placebo in about 200 patients. The primary endpoint is the percentage change from baseline in seizure frequency during the treatment period.
GW Pharmaceuticals CEO Justin Gover said: "Our decision to evaluate Epidiolex in TSC is based on findings from the physician-led Epidiolex expanded access program, which found that TSC patients reported reductions in seizure activity.
"With the commencement of this trial, GW’s Epidiolex development program now encompasses three rare epilepsy indications with pivotal trials fully underway. GW is committed to establishing Epidiolex as a new therapy to address the significant unmet need among patients who have few treatment options."
Epidiolex is a liquid formulation of pure plant-derived CBD, which is in development to treat several rare pediatric epilepsy disorders.
It is currently in late-stage development for the treatment of Dravet syndrome and Lennox-Gastaut syndrome, both forms of epilepsy.
GW has undertaken pre-clinical research of CBD in epilepsy since 2007. The research demonstrated that CBD has significant anti-epileptiform and anticonvulsant activity using several in vitro and in vivo models.
It has also shown that CBD has the ability to treat seizures in acute animal models of epilepsy with significantly fewer side effects, when compared to existing anti-epileptic drugs.