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Oral CBD Epidyolex Reclassified as Over-the-counter Drug in UK

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Oral CBD Epidyolex Reclassified as Over-the-counter Drug in UK
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The United Kingdom Home Office has reclassified Epidyolex (cannabidiol, or CBD) as a Schedule 5 drug, making it easier to obtain for patients with rare epileptic disorders such as Lennox-Gastaut syndrome.

Epidyolex (known as Epidiolex in the U.S.) is an oral cannabidiol solution derived from the cannabis, or marijuana, plant. Because cannabidiol is a non-psychoactive extract from marijuana, the treatment does not have the characteristic “high” effect that is associated with marijuana use.

Made by GW Pharmaceuticals, Epidyolex had previously been classified as a Schedule 2 drug, on the same order as methadone and heroin. As such, it was heavily regulated and required a prescription. As a Schedule 5 drug, it may be sold over the counter and legally possessed without a prescription.

“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 Chris Tovey, GW’s chief operating officer, 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.”

The new classification lifts a burden from patients and their families, and healthcare professionals. In an official Home Office announcement, the government notes that the new schedule removes restrictions around prescribing Epidyolex and extends the length of time for which a prescription is valid.

The reclassification also lifts the Department of Health and Social Care’s recommendation of a maximum 30-day supply of the medication. This is expected to lower costs to patients and healthcare providers by reducing a patient’s number of needed visits.

The change further lowers logistical costs to healthcare providers by easing requirements for supplying, record-keeping, labelling, destruction, and safe custody of the medicine.

The Advisory Council on the Misuse of Drugs and its technical committee recommended the change based on data that showed a low risk for potential abuse, dependency, and diversion (the transfer of a controlled substance from lawful to unlawful channels of distribution or use). The council noted that Epidyolex is distinct from other compounds that contain CBD and that, as such, the new classification applies exclusively to Epidyolex.

The change takes effect immediately in all four countries of the U.K. — England, Wales, Scotland, and Northern Ireland — although Northern Ireland is enacting its own 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.

Epidiolex was approved by the U.S. Food and Drug Administration in 2018 for the treatment of seizures in Lennox-Gastaut syndrome and Dravet syndrome patients, ages 2 and older. Under the brand name Epidyolex, the therapy was approved by the European Commission the following year for the same indication as an add-on therapy to clobazam.

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