- GW Pharma's Epidiolex is an oral drug made from cannabidiol, a non-psychoactive part of the marijuana plant. It has been in development for various medical conditions, including Dravet syndrome, a rare form of epilepsy in children.
- In a phase 3 trial involving 120 patients, treatment with Epidiolex resulted in a median 39% reduction in seizures, compared with 13% in placebo-treated patients. Results were deemed statistically significant.
- Based on the strength of this data. GW Pharma is requesting a meeting with the FDA to chart out a regulatory pathway to approval.
GW Pharma has been around since 1998, focusing on developing cannabis-based drugs and exploiting the intrinsic therapeutic properties of cannabis. So far, its approved drug, Sativex, used as an under-the-tongue spray to treat multiple sclerosis (MS), has been approved in more than 20 countries -- but not the U.S.
GW has faced numerous challenges during the last 17 years, some of which may be due to the stigma associated with cannabis. However, the company has produced positive therapeutic results in studies involving not only MS and Dravet syndrome, but also schizophrenia.
GW initially built a base of evidence from use of Epidiolex in children with Dravet syndrome under a compassionate use program. The data were positive. However, it was not until the new phase 3 data were generated that the market really responded to the good news.
The stock doubled after the release of the Phase 3 data and is now at $82.26. It has a 52-week low of $35.83 and a 52-week high of $133.98.