A CBD-based medical cannabis product – Epidyolex/Epidiolex – was rescheduled in the UK last month. The drug, licensed for the treatment of some forms of Epilepsy, was fast-tracked to the NHS last year, following recommendations by the National Institute for Health and Care Excellence.
In June (2020), the Home Office move Epidyolex to schedule 5 of the Controlled Substances Act. Prior to the move, Epidyolex – along with other medical cannabis products – was classified as a schedule 2 drug after being moved from schedule 1 in November 2018. The move is expected to make it easier for patients in the UK to access the medication.
According to the Home Office announcement on the rescheduling of Epidyolex:
“This will reduce administrative processes for companies wanting to supply Epidyolex to patients with severe epilepsy.”
What is Epidyolex?
A number of clinical studies have assessed the potential of cannabis products as a treatment option for epilepsy. Many of these studies have found that cannabinoids may reduce spasticity in some forms of the condition. High profile patient cases in the UK include Alfie Dingley and Billy Caldwell whose families have passionately campaigned for easier access to the medication.
Epidyolex – Epidiolex in the USA – is produced by GW Pharmaceuticals is a majority CBD-based cannabis product. Pure CBD (cannabidiol) is legal in the UK, as it does not produce the ‘high’ often associated with cannabis. However, medical products such as Epidyolex are controlled in the country due to small amounts of THC – mostly known for its psychoactive effects.
Access to Medical Cannabis Products in the UK
Medical cannabis was only effectively legalised in the UK in late 2018, following the rescheduling of the drug. The move from schedule 1 to schedule 2 allowed specialist doctors to prescribe medical cannabis products for a limited range of conditions.
However, access to medical cannabis products has remained limited in the time since the rescheduling. This is largely due to a lack of clinical evidence, needed for the National Institute of Health and Care Excellence (NICE) to make meaningful recommendations on the use of the products. NICE’s 2019 report only recommended the use of medical cannabis products for a handful of conditions.
The rescheduling of Epidyolex represents the first time that a cannabis-based medicine has been placed in Schedule 5 of the Controlled Substances Act. It is hoped that the move will reduce red-tape for specialist prescribers. In addition, the length of validity for prescriptions will be extended, and patients may gain access to increased quantities of the medication.
Epidyolex and GW Pharmaceuticals
Epidyolex is the only medical cannabis product recommended as an adjunct therapy for Lennox-Gastaut and Dravet syndromes of epilepsy. Another GW Pharmaceuticals drug, Sativex, became the first medical cannabis product to be classified on schedule 4 of the Controlled Substances Act. Unlike Epidyolex, Sativex contains significant concentrations of THC.
