GW Pharmaceuticals’ Epidyolex has been rescheduled in the UK, making life easier for patients, healthcare professionals and pharmacists.
Epidyolex, which is marketed as Epidiolex in the USA, is a cannabidiol based medication used for managing seizures associated with certain conditions.
As Epidiolex, in June 2018 it was the first cannabis-derived medicine to be approved by the USDA’s FDA. In April this year, the United States Drug Enforcement Administration (DEA) determined Epidiolex was no longer subject to the Controlled Substances Act (CSA); i.e. it was descheduled.
As Epidyolex, it received marketing authorisation for treating certain conditions in all 28 EU countries as well as Norway, Iceland and Liechtenstein in September last year.
Earlier this week, the UK Home Office rescheduled Epidyolex from a Schedule 5 to Schedule 2 drug under the Misuse of Drugs Regulations 2001. The nature of the change in the Regulations means that the downscheduling applies to Epidyolex only.
The decision to reschedule was based partly on the advice of the Advisory Council on the Misuse of Drugs, which noted a low risk of abuse potential, low risk of dependency and low risk of diversion.
“The decision to move Epidyolex to a low level of control is an important one for patients, their families, healthcare professionals, pharmacists and the NHS as a whole – reducing costs and ensuring the medicine can be dispensed more easily,” said GW Pharmaceuticals Chief Operating Officer Chris Tovey.
Reducing costs will be an important plus. Epidyolex/Epidiolex is very expensive; although in the UK the cost can be covered by NHS – still, the cost is then borne by taxpayers.
Commenting further on other benefits from the change, GW said:
“Patients and their families will now have greater flexibility on the quantity of medicine they can receive and be able to benefit from repeat prescriptions, thereby potentially reducing travel to hospital pharmacies, whilst healthcare professionals and pharmacists will benefit from reduced controls around the storage and reporting requirements that exist for medicines under Schedule 2.”
While a prescription isn’t necessary for Schedule 5 drugs under the Misuse of Drugs Regulations 2001 in order to obtain products, it is for NHS coverage.
Cannabidiol in other forms is also readily (and much more cheaply) available in the UK – however, these products are marketed as supplements rather than as medications and quality has been a concern; leading to a crackdown by the Food Standards Agency (FSA).