What does this mean?
A schedule 2 drug means that the drug is only allowed to be lawfully possessed and sold with strict record-keeping, whereas the schedule 5 classification means it can be sold and possessed with fewer restrictions and administration.
This rescheduling means more flexibility for patients when it comes to how much of the medication they can gain access to, as well as easing restrictions for pharmacists when it comes to storage and reporting requirements than when it was a schedule 2 substance.
Although medical cannabis was legalised in the UK in 2018, access to medical cannabis products has remained difficult for patients, due to NICE only recommending the use of certain medical cannabis products for a small number of health conditions. However, this specific rescheduling of the CBD-based medical cannabis product ‘’Epidyolex’’ is the first time a cannabis-based medicine has been placed in schedule 5 of the Controlled Substances Act.
What is Epidyolex?
Epidyolex is a cannabinoid medication that is licensed for the treatment of severe types of epilepsy, and this rescheduling to the least strict classification by the Home Office was a giant step toward making it more easily available for UK patients. Previously, Epidyolex had been classified as a schedule 1 drug until it was moved to schedule 2 in 2018.
Epidyolex as known in the EU, and Epidiolex in the US is an oral medication of cannabidiol (CBD), the non-psychoactive cannabinoid found in the cannabis plant. Epidyolex was introduced to the UK’s NHS in 2019, after the National Institute for Health and Care Excellence (NICE) put forward its recommendations in the drugs ability to treat severe forms of epilepsy, such as Lennox Gastaut Syndrome and Dravet Syndrome. This fast-tracking into the NHS happened after clinical trials revealed that combination therapies that included Epidyolex helped to lower the number of seizures in children by up to 40%.
Although in the UK, cannabidiol (CBD) is not a controlled substance, Epidyolex and other types of CBD medication are usually controlled due to them containing small amounts of tetrahydrocannabinol (THC). THC is the most well-known and studied psychoactive ingredient of the cannabis plant. However, it isn’t only the UK that has begun to relax its restrictions when it comes to medical cannabis, there are several other European countries, including Germany, Portugal, Denmark, and Poland, who have begun to relax their restrictions surrounding medical cannabis over the past three years.
This change in classification is expected to ease access to the medication for patients in the UK, as well as reduce the amount of paperwork and administration for companies who want to supply the drug to patients- although it is too early to see if this is the case, as of yet.
This reclassification of Epidyolex is just another step in the right direction, in discovering the possibilities and potentials when it comes to medical cannabis.