GW Pharmaceuticals, a biopharmaceutical company focused on discovering, developing and commercialising novel therapeutics from its proprietary cannabinoid product platform, has initiated the second Phase 3 clinical trial of Epidiolex? (cannabidiol or CBD) for the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy.
This follows GW’s recent announcement of the commencement of the first Phase 3 clinical trial of Epidiolex in Dravet syndrome. GW expects to complete patient recruitment into this second trial in 2015 and to report top-line results in early 2016.
GW plan to submit a New Drug Application for Epidiolex in mid-2016
“The start of our second pivotal Phase 3 clinical trial for Epidiolex in the treatment of Dravet syndrome marks another key milestone in our plan to submit a New Drug Application for Epidiolex to the FDA in mid-2016,” stated Justin Gover, GW’s Chief Executive Officer. “Therapeutic options for patients with Dravet syndrome are limited and GW is committed to bringing Epidiolex to the market as quickly as possible and to offering a new option to address this significant unmet need.”
The Phase 3 trial is a 14-week comparison of Epidiolex versus placebo in a total of 150 patients to assess the safety and efficacy as an adjunctive antiepileptic treatment. This Phase 3 trial will have three treatment arms of equal patient numbers; 20mg/kg of Epidiolex, 10mg/kg of Epidiolex, and placebo. The primary measure of this trial will be the percentage change from baseline in convulsive seizure frequency during the maintenance period of the study in patients taking Epidiolex versus placebo. Several additional efficacy and safety secondary outcome measures will be analysed. Following their participation in the study, all patients are eligible to receive Epidiolex under a long term open label extension study.
GW also expects to commence two Phase 3 clinical trials in Lennox-Gastaut syndrome in the second quarter of 2015.
