UK Eases Restrictions on Epidyolex for Treating Epileptic Disorders

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Epidyolex designation

The United Kingdom Home Office has changed the classification of GW Pharmaceuticals‘ Epidyolex — a treatment for epileptic conditions including Dravet syndrome — from a Schedule 2 drug to a Schedule 5 drug. This move will make the medication easier to obtain.

“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 [National Health Service] as a whole — reducing costs and ensuring the medicine can be dispensed more easily,” Chris Tovey, chief operating officer of GW, said in a press release.

Epidyolex (known as Epidiolex in the U.S.) is an oral solution of cannabidiol (CBD). CBD is derived from the cannabis plant, but it is not psychoactive — that is, it doesn’t induce the “high” commonly associated with cannabis use.

The medication has been approved by the U.S. Food and Drug Administration and by the European Commission to treat seizures in people age 2 and older with Dravet syndrome and Lennox-Gastaut syndrome.

Under its previous designation as a Schedule 2 drug — alongside drugs such as heroin and methadone — Epidyolex was heavily regulated, requiring a prescription to obtain. The new classification makes Epidyolex legal to be sold over the counter and legal to possess without a prescription.

As noted in an official Home Office announcement, the new scheduling lifts a previous recommendation from the Department of Health and Social Care, which limited availability of the medication to a 30-day supply at a time. This is expected to lower the number of appointments patients need to have with their healthcare providers, which could lower associated costs.

The new scheduling also makes it easier to import and export the medication, and it eases requirements for supplying, record-keeping, labeling, destroying, and safely storing Epidyolex, which is expected to decrease the logistical burden incumbent on healthcare providers.

The Advisory Council on the Misuse of Drugs (ACMD) and its technical committee recommended the scheduling change based on data that showed Epidyolex has a low potential risk for abuse, dependency, and diversion (moving a controlled substance from lawful to unlawful channels for use or distribution).

“The extensive pre-clinical and clinical data that GW developed to support the medicine’s approval by regulatory authorities was pivotal to this important schedule change, and we would like to thank the MHRA [Medicines and Healthcare products Regulatory Agency], ACMD and Home Office for scrutinising this data and making this change in such a short timeframe,” Tovey said.

The new designation specifically applies to Epidyolex; it does not affect the status of other CBD-based medications. The change takes effect immediately in all four countries of the U.K. (England, Wales, Scotland, and Northern Ireland), although Northern Ireland is enacting separate legislation.

“We remain committed to expanding the high-quality evidence base for cannabis-based medicines and securing further regulatory approvals because doing so is in the interests of patients and healthcare professionals and can support further rescheduling,” Tovey said.