GW Pharmaceuticals plc has begun Phase 3 of its Phase 2/3 clinical trial of Epidiolex ® (an oral liquid formulation of a highly purified extract of CBD, a non-psychoactive molecule from the cannabis plant for the treatment) of Dravet syndrome. Dravet is a rare and catastrophic treatment-resistant form of childhood epilepsy. According to Orrin Devinsky MD, Professor of Neurology, Neurosurgery, and Psychiatry at NYU School of Medicine, and Principal Investigator of the trial, there are approximately 5,440 cases here in the US, with an estimated 6,710 in Europe, although he admitted that the disease is often underdiagnosed.
Seizures from Dravnet Syndrome are triggered by are often triggered by hot temperatures or fever, and generally begin around 6-months of age. They can then progress to other seizure types such as myoclonic and partial seizures, psychomotor delay and ataxia. Characteristics of the disease includes impaired cognition, behavioral disorders such as hyperactivity and impulsiveness and in more rare case autisic-like behaviors, as well as “ motor deficits. Dravet syndrome is also associated with sleep disorders including somnolence and insomnia.
“This clinical trial is the first ever rigorous placebo-controlled trial of pure pharmaceutical cannabidiol (CBD) in the field of epilepsy and, as such, a trial of significant interest for the entire epilepsy physician and patient communities, he continued Devinsky.
According to GW Pharmaceuticals CEO Justin Gover, the company has been specializing in the “discovery, development and commercialization of novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas since 1998, including the world’s first plant-derived cannabinoid prescription drug, Sativex(R), which is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside the US.” The company is also expected to enter Phase 3 clinical trials in the treatment of Lennox-Gastaut syndrome, while further investigating Sativex’s use in treating pain associated with advanced cancer, as well as compounds in Phase 1 and 2 trials for ulcerative colitis, type 2 diabetes, and schizophrenia.
Readers interested in learning more about Dravnet Syndrome can visit the Dravet.org at www.dravet.org;
The Dravet Foundation at www.dravetfoundation.org or ICE Epilepsy Alliance/Intractable Childhood Epilepsy www.ice-epilepsy.org