The United Kingdom has down-scheduled Epidyolex to the lowest level of control for drugs, greatly easing restrictions on the cannabidiol medicine and reducing administrative processes for companies wanting to supply it.

The UK said the new provisions – made through the Misuse of Drugs (Amendment) (England, Wales and Scotland) Regulations 2020 – came into force June 24.

“By placing Epidyolex in Schedule 5 to the 2001 Regulations, it is no longer subject to the prohibition on importation, exportation and possession under the 1971 Act,” according to the government’s circular announcing the change.

“This will reduce administrative processes for companies wanting to supply Epidyolex to patients with severe epilepsy.”

Epidyolex is the trade name in Europe for Epidiolex.

London-based GW Pharmaceuticals, the maker of Epidyolex, said the move exempts the medicine from most controlled drug requirements.

“The decision to move Epidyolex to a low level of control is an important one for patients, their families, healthcare professionals, pharmacists and the (National Health Service) as a whole – reducing costs and ensuring the medicine can be dispensed more easily,” Chris Tovey, chief operating oficer, said in a press release.

The 2001 regulations facilitate access to controlled drugs for medical purposes.

In the UK, Epidyolex is licensed for use as an supplementary treatment for rare forms of epilepsy.

The down-scheduling provides for a lower level of control and extends the length of time a prescription can be valid for.

Epidyolex will no longer be subject to the Department of Health and Social Care’s recommendation of a maximum 30-day supply, the government said.

“This may help reduce the number of appointments needed for patients, with prescribers, saving time and reducing costs for both patients and healthcare professionals,” the circular notes.

In 2018, cannabis-based medical products were placed in Schedule 2 to the 2001 Regulations, allowing them to be prescribed in the UK.

A year later, the European Commission issued a marketing authorization to Epidyolex.

GW ended 2019 with $311.3 million in sales.

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Originally posted on via Cannabis Industry News