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UK down-schedules Epidyolex to lowest level for controlled drugs

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 U.K. 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, health-care professionals, pharmacists and the (National Health Service) as a whole – reducing costs and ensuring the medicine can be dispensed more easily,” Chris Tovey, GW Pharma’s chief operating officer, said in a news release.

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

In the U.K., Epidyolex is licensed for use as a 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.

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 health-care professionals,” the circular notes.

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

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

GW ended 2019 with $311.3 million in sales.

GW Pharma trades on the Nasdaq as GWPH.

The Misuse of Drugs Act 1971 is available here and the Misuse of Drugs Regulations 2001 here.

The amendment pertaining to the down-scheduling of Epidyolex can be found here.

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