GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) reported that the New England Journal of Medicine has issued report from a Phase III trial of Epidiolex in children with Dravet syndrome. Epidiolex is a liquid formulation of refined, plant-derived Cannabidiol, a non-psychoactive cannabinoid. It is being evaluated for the treatment of different rare, grave pediatric-onset epilepsy ailments.
In the trial, GW Pharmaceuticals Epidiolex significantly lowered monthly convulsive seizure frequency as against placebo in highly treatment-resistant kids when added to standard care of treatment. Epidiolex treatment was well-tolerated, with a safety profile unswerving with previous open label experience.
GW Pharmaceuticals reported that as of now there are no treatments permitted by the U.S. FDA for Dravet syndrome, an uncommon form of epilepsy related with a high mortality rate and considerable advancement delays. Report from this trial showcase the only well-controlled clinical assessment of a cannabinoid drug for this devastating and drug-resistant ailment. The NDA for Epidiolex continues to be on track for filing to the FDA in the mid-2017.
Orrin Devinsky, M.D., who is the lead author of the trial, mentioned that Dravet syndrome comes in the list of the most severe types of epilepsy to treat in children and several kids in this study were witnessing many seizures per month regardless of taking numerous concurrent anti-epileptic drugs. These results indicate that Epidiolex can offer clinically meaningful advantages and they look forward to the opportunity of an appropriately tested and standardized pharmaceutical formulation of Cannabidiol accessible as a treatment alternative for these patients.
Nicole Villas reported that the issue of these highly-projected positive results exhibits a vital breakthrough for the Dravet syndrome group in that it offers hope that a new treatment alternative is within sight for this devastating and rare disease. As a foundation committed to research and patient help, they expect the affliction of Dravet syndrome on patients and their families is accepted and welcome new, well-researched therapies that can help ease the burden.