GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) and its subsidiary Greenwich Biosciences have announced that results of their clinical study on cannabidiol on a difficult-to-treat epilepsy have been published in the Lancet. The firm, which develops novel therapautics from its cannabinoid platform said that the controlled study demonstrated that formulated cannabinoid could significantly drop the frequency of seizures on patients who are poor in controlling seizure.
The published results, part of a phase three study on the firm’s proprietary platform, Epidiolex show that the drug could be a potential solution to people suffering from Lennox-Gastaut syndrome, a rare early childhood-onset epileptic disorder.
Following the results, GW Pharmaceuticals submitted a new drug application to the U.S Food and Administration for the use of Epidiolex to treat LGS. The application was accepted in December last year. However, if approved, Epidiolex could hit the shelves in the second half of 2018 as a prescription only medicine. At the same time, the firm submitted a Market Authorization Application to the European Medicines Agency which is expected to give its decision early 2019.
According to GW’s CEO Justin Gover, the publication of of the landmark study is an major milestone for the company. Last year, the New England Journal of Medicine became the first major publication to list Epidiolex data. The CEO further added that the publications show the high potential of Epidiolex in addressing the needs of challenging epileptic disorders like LGS and Dravet Syndrome, another rare condition.
“We are focused on making this important medicine available to millions of patients and their caregivers as soon as possible,” said GW CEO. LGS is a lifelong, drug resistant epilepsy. It has a high mortality rate and developmental delays. As such, patients suffering from this type of epilepsy have to contend with different types of seizures, including the drop seizure.
According to Christina Saninocencio, the the Lennox-Gastaut Syndrome Foundation executive director, the publication of these results marks an important milestone for LGS patients. She said the Epidiolex solution offers hope to many patients who are suffering form the debilitating conditions.
Elizabeth Thiele, director of pediatric epilepsy at Massachusetts General Hospital said that LGS was one of the toughest types of epilepsy, adding that most LGS patients do not respond well to existing therapies.The study was carried out in 24 study centers in the USA and Europe.