Regulators in the United Kingdom have rescheduled the cannabidiol drug Epidyolex as a Schedule 5 drug, moving the medicine approved to treat severe forms of epilepsy from the much more restrictive Schedule 2 classification. GW Pharmaceuticals, the manufacturer of the medication, announced on Tuesday that the move by the Home Office would take effect in all four constituent nations of the U.K. immediately, with Northern Ireland enacting separate legislation.
“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 (NHS) as a whole – reducing costs and ensuring the medicine can be dispensed more easily,” said Chris Tovey, the CEO of GW, in a press release. “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.”
Approved As Treatment For Severe Epilepsy
Epidyolex is a flavored oral solution with cannabidiol (CBD) that reduces seizures in children with epilepsy. The medicine, which is not psychoactive, also contains less than 0.1 percent THC. Epidyolex, which is produced by GW Pharmaceutical at its facilities in the U.K., was approved for use as a treatment for two severe forms of childhood-onset epilepsy by the European Union last autumn.
The U.K. Advisory Council on the Misuse of Drugs (ACMD) and its Technical Committee recommended the schedule change for Epidyolex in January of this year. The ACMD cited the “low risk of abuse potential, low risk of dependency and low risk of diversion” as justification for the reclassification from a Schedule 2 controlled drug to Schedule 5. The ACMD also noted that Epidyolex is “distinct from other commercially available CBD (cannabidiol) containing supplements that have not sought marketing authorization as a medicine” and that the schedule change therefore only applies to GW’s formulation.
Changing the classification of Epidyolex from Schedule 2 to Schedule 5 removes it from nearly all of the U.K.’s requirements for controlled drugs. GW said the change will make it easier for patients to obtain their medicine and relieve health care professionals and pharmacists from burdensome storage and reporting requirements.
Drug Also Available In The US
In the United States, the drug is marketed by GW under the trade name Epidiolex. In June 2018, the drug was approved by the U.S. Food and Drug Administration as a treatment for Lennox-Gastaut syndrome and Dravet syndrome, two debilitating forms of childhood epilepsy that can cause dozens or even hundreds of seizures per day and often cannot be treated successfully with other medications.
In September 2018, the DEA changed the classification for Epidiolex, moving it from Schedule 1 to Schedule 5, although the change does not apply to CBD itself or other drugs containing the cannabinoid. Earlier this year, the DEA removed Epidiolex from the nation’s list of controlled substances.