A cannabinoid medication marketed by GW Pharmaceuticals for the treatment of severe forms of epilepsy will be available to patients in the UK without the need for a prescription after the drug was moved to the least strict classification by the country’s Home Office.
The medication — branded as Epidyolex in the EU and Epidiolex in the US — is an oral solution of cannabidiol, a non-psychoactive ingredient of cannabis. The drug was fast-tracked into the UK’s National Health Service late last year to treat forms of epilepsy such as Lennox Gastaut syndrome and Dravet syndrome. This came after clinical trials showed a combination therapy including Epidylolex helps reduce the number of seizures in children by up to 40%.
Until now, the drug was classified as a schedule 2 drug, meaning that it could only be lawfully possessed with a prescription. The Home Office has now made it a schedule 5 drug, which can be sold over the counter with much less paperwork. This means that patients get more flexibility regarding how much of the drug they can obtain, and also that pharmacists have fewer storage and reporting requirements than before.
“This is the first time a cannabis-based medicine has been classified as a schedule 5 medicine,” Michael Trace, GW Pharmaceuticals’ public relations representative, told me.
Pure cannabidiol is not a controlled substance in the UK because it’s not seen to carry a risk of drug abuse. However, Epidyolex and other CBD products are typically controlled in the UK because they contain small amounts of tetrahydrocannabinol (THC), cannabis’ best-known psychoactive ingredient, which can carry a risk of drug abuse.
“THC is a schedule 1/2 drug in the UK. But given that it is at such a low concentration in Epidyolex and the risk of abuse is extremely low, then a schedule 5 is appropriate,” explained Andy Yates, pharmacy lead of the industry association Center for Medicinal Cannabis. He added that this same approach is also used with other controlled substances such as codeine and opium.
While it’s still unclear how Epidyolex’s reclassification will impact the wider cannabidiol market, “this approach could be a sensible mechanism by which the Home Office could deal with wellness and over the counter CBD products that contain trace amounts of THC,” Yates said.
In a similar vein, the CEO of UK cannabinoid supplier Grow Pharma, Pierre van Weperen, told me the Home Office’s decision on Epidyolex is mostly symbolic; a safety assertion on CBD. But as such, it is expected to increase doctors’ and patients’ confidence in Epidyolex and similar CBD-based drugs.
GW Pharmaceuticals is a heavyweight in the cannabinoid drug field. For example, Epidiolex made history as the first cannabinoid treatment to be approved by the FDA for the treatment of epilepsy in 2018. In April of this year, the drug was taken off the controlled substances list in the US.
In 2013, GW Pharmaceuticals also pushed the limits of the UK drug classification system by getting a cannabis-derived oral spray for multiple sclerosis called Sativex reclassified as a schedule 4 drug. In contrast to Epidyolex, Sativex contains significant amounts of THC.
The UK is one of several European countries that have relaxed medical cannabis restrictions over the past three years. Germany arguably set the trend in 2017, followed by the UK, Portugal, Denmark, and Poland. Many in the industry, however, say the UK has been slow to adapt to the global trends in cannabis-based biotechnology.
“The two most important regulations for the UK to be changed are the very strict limitations on importing THC or THC-containing products, which create issues around availability and cost for patients that could easily be resolved,” said van Weperen of Grow Pharma.
“The other issue is in terms of allowing the UK to export CBD- and THC-containing products. The UK could very well become a leader in European medicinal cannabis if these regulations were relaxed.”
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