On June 25, 2018, the U.S. Food and Drug Administration approved Epidiolex, the first drug to be created with CBD isolate. GW Pharmaceuticals created the medication after studies showed surprising success treating severe childhood epilepsy, specifically Lennox-Gastaut Syndrome and Dravet Syndrome.
Now, Marijuana Business Daily reports that the European Commission has just approved the drug as well. Unlike most antiepileptic drugs, CBD was found to have minimal side effects and pose no risk to brain development.
Dravet and LGS are also notoriously resistant to conventional treatment, leaving many children unable to live normal lives due to multiple daily seizures. Although rare, those who suffer from either of these disorders suffer substantially.
Thanks to these observations in the U.S. study, the 26,000 Dravet and 130,000 LGS patients in Europe have a new alternative that could bring hope to a seemingly hopeless situation.
Available Across Europe
Thanks to the centralized nature of the European Union, this single approval essentially gives all members access to Epidiolex.
The Phase 3 trials were what convinced officials to give Epidiolex the green light. However, evidence of efficacy is not always necessary to get something approved.
According to Marijuana Business Daily:
“Normally, European countries that allow the prescription of medical cannabis without proven efficacy do so only after prioritizing the prescription of medicines with marketing authorization.”
With Epidiolex being a prescription drug, this effectively allowed it to skip ahead of less extensively-studied drugs like unregulated CBD or marijuana.
“Manufactured to the Highest Standards”
Marijuana laws differ from one European country to another. It is prohibited recreationally (although Luxembourg plans to change that) and allowed for medical consumption in certain countries.
This forces individuals to use unregulated CBD “health supplements,” which more often than not contain less CBD than advertised or possibly no CBD at all.
Epidiolex, however, gives patients access to legal, regulated CBD. GW Pharmaceuticals said in a press release:
“This approval is the culmination of many years of dedication and collaboration between GW, physicians and the epilepsy community. 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.”
In the U.S., Epidiolex costs $32,000 USD per year. But given the amount of CBD needed to treat this condition, patients using marijuana or unregulated hemp products will spend much more.
But given the different healthcare systems throughout Europe, it is possible that pricing will vary.
WeedAdvisor’s Support for Cannabis Expansion
We have always advocated for easy accessibility to legal medical marijuana. Unfortunately, this is not an option in many countries. But drugs like Epidiolex help bridge that gap by using cannabis as its primary ingredient in a prescription medication.
By placing CBD into mainstream medicine, anyone can access it would the need for a medical marijuana license, nor do they have to wait indefinitely for their state or country to legalize cannabis.