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UK Home Office Deschedules Epidyolex

By Leo Bear-McGuinness

Published: Jun 25, 2020   
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The UK Home Office has reclassified Epidyolex, a CBD-based medication, under the lowest level of control for drugs in the country.

In an announcement on June 24, the drug’s manufacturer, GW Pharmaceuticals, said the move from Schedule 2 to Schedule 5 took immediate effect across the UK.

Now exempt from many controlled drug requirements, GW says the drug should become more accessible for patients.

Dialed back

Back in 2018, Epidiolex – the drug’s altered name in the US – became the first cannabinoid drug approved for use by the FDA. After reviewing three randomized, double-blind, placebo-controlled clinical trials involving 516 patients, the strawberry-flavored CBD solution was deemed to be a safe and effective treatment for children with Lennox-Gastaut and Dravet syndrome, two severe forms of epilepsy.

Over in the UK, Epidyolex was approved for use by England’s National Health Service (NHS) last November. But the drug remained as a Schedule 2 substance, which ranked it alongside cocaine and ketamine. And, under the Misuse of Drugs Regulations act of 2001, supply and procurement of Schedule 2 drugs can only be authorized by pharmacists and other such health professionals.

But now, as a Schedule 5 drug, Epidiolex could become exempt from virtually all controlled drug requirements other than “retention of invoices for two years.”

“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,” Chris Tovey, GW Pharma’s chief operating officer, said in a statement.

“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 [Advisory Council on the Misuse of Drugs], and Home Office for scrutinizing this data and making this change in such a short timeframe,” Tovey continued.

“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.”

Epidiolex, CBD, and epilepsy

In April this year, US’s Drug Enforcement Administration (DEA) also moved Epidiolex from a strict drugs list, this one being the Food and Drug Administration’s (FDA) list of controlled substances.

The CBD solution was also approved for use in the European Union last September.

But despite its increasing acceptance, some scientists are still concerned about its effectiveness. In late 2019, a paper published in the British Journal of Clinical Pharmacology argued that the beneficial effects seen in clinical trials of Epidiolex could actually be attributed to a drug-drug interaction between CBD and clobazam, another common anti-epileptic medication. 

“I went back to [two of the three cited] papers… and I thought, ‘let’s have a look.’ How many of those patients were actually using clobazam?” Geert Jan Groeneveld, the study’s lead author, told Analytical Cannabis last November.

“And I was awestruck,” he said. “I was flabbergasted when I saw that 50 percent in one study and 60 percent in the other study were actually using this other drug, clobazam.”

“I'm not saying that I know for a fact that cannabidiol does not have any anti-epileptic effects. What I am saying is, I can explain the effects that you've observed through elevated blood levels of clobazam.”

Since being approved by the FDA in 2018, more than 15,000 US patients have taken Epidiolex. GW Pharmaceuticals earned $86.1 million in revenue from the drug in 2019’s first quarter alone.


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