After winning regulatory approval overseas last year, UK-based GW Pharmaceuticals finally received the nod from the European Commission this week for its cannabidiol (CBD) drug, Epidyolex. At this time, the cannabis-derived medication is only approved in the US and EU.
The European Commission approval closely matches that of its US counterpart, Epidiolex; it’s intended to be used with clobazam for the treatment of two rare forms of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome, in patients two years of age and older. Both diseases are usually diagnosed in early childhood and are notoriously difficult to treat. The severity and frequency of seizures can lead to cognitive or motor delays.
“The approval of cannabidiol oral solution is a very important step for patients and families whose lives are significantly influenced by these rare and complex life-long and drug resistant diseases,” said Isabella Brambilla, president of the Dravet Syndrome European Federation and of the Dravet Italia Onlus, in an email to Xtalks. “We are very happy to have a new treatment option, that could improve the quality of life (reduction of seizures in terms of frequency and duration and other related benefits) of affected patients and consequently of their families.”
Epidyolex is a highly purified form of CBD, the primarily non-psychoactive component of cannabis. While the exact mechanism of action of CBD is unclear, some research suggests it can treat chronic pain, cancer and some psychiatric conditions.
Cannabis is still considered to have no accepted medical use and high abuse potential under schedule I of the Controlled Substances Act (CSA) in the US. However, growing research on the flower’s constituents and derivatives may have driven the Drug Enforcement Administration (DEA) to consider CBD and hemp differently. Three months following its approval, the DEA announced that Epidiolex would be placed in schedule V of the CSA, the least restrictive schedule of the Controlled Substances Act. Since the 2018 Farm Bill removed hemp and CBD-derived products from the definition of marijuana, consumers have also seen a surge in CBD-derived products.
A 2018 document published by the European Monitoring Centre for Drugs and Drug Addiction illustrates just how complex the legislative landscape is. At this time, no country officially authorizes cannabis smoking for medicinal purposes, but the types and severity of penalties for medical and industrial cannabis use vary across countries.
The approval of Epidyolex makes the drug available to all 28 EU member states, including Norway, Iceland and Liechtenstein. “This will bring hope to patients and families, with the potential to better control seizures and improve quality of life,” said Professor Elinor Ben-Menachem from the University of Goteborg, Sahlgren Academy and Hospital in Sweden.
“We believe patients and physicians deserve access to rigorously tested and evaluated cannabis-based medicines, manufactured to the highest standards and approved by medicines regulators, and we are delighted to be the first to offer this solution to the epilepsy community,” added Justin Grover, CEO of GW Pharmaceuticals.
The pharma company is currently seeking US approval for its cannabis-based oromucosal spray, nabiximols, for the treatment of muscle spasms in multiple sclerosis.