News Feature | May 9, 2014

FDA Confirms GW Pharmaceuticals' IND For Epidiolex Trial In Dravet Syndrome

By Estel Grace Masangkay


GW Pharmaceuticals announced that it has received confirmation from the U.S. Food and Drug Administration (FDA) for its Investigational Drug (IND) application for Epidiolex trial in rare illness Dravet Syndrome. GW is a biopharmaceutical company that uses its proprietary cannabinoid product platform for novel drugs discovery and development.

Dravet syndrome is a rare, catastrophic form of epilepsy also known as Severe Myoclonic Epilepsy of Infancy (SMEI). The disease is also a treatment-resistant form of childhood epilepsy, which induces seizures in an infant’s first year of life. Initial seizures are mostly prolonged attacks with other types of seizures emerging in patients’ second year of life. Prognosis for patients with Dravet syndrome is poor, with affected infants facing a higher incidence of sudden unexplained death in epilepsy (SUDEP).

Epidiolex is an oral liquid formulation of a highly purified extract of plant-derived cannabidiol (CBD). CBD is a non-psychoactive molecule from the cannabis plant. The FDA has previously granted the investigational therapeutic Orphan Drug designation for the treatment of Dravet syndrome. The company plans to start a Phase II/III clinical trial in the second half of this year.

Justin Gover, GW Pharmaceuticals CEO, said, “The acceptance of this IND by the FDA is a significant milestone for Epidiolex and for children with Dravet syndrome for whom existing anti-epileptic medicines often do not provide adequate relief. This journey began with requests from the U.S. epilepsy physician and patient community to utilize Epidiolex and has now led to GW embarking on its own formal development program with a view to seeking market authorization from the FDA as rapidly as possible.” CEO Gover said that the company will seek ways to deliver prescription cannabidiol (CBD) treatment for pediatric patients with Dravet syndrome who have no alternative therapeutic options.

The company said it expects to launch an additional Phase III trial in Dravet Syndrome early next year that will parallel part two of the first Phase II/III trial.