DEA Removes Epidiolex From the Controlled Substances List

The US’s Drug Enforcement Administration (DEA) has removed Epidiolex, a CBD-based medication, from the Food and Drug Administration’s (FDA) list of controlled substances.

GW Pharmaceuticals, the manufacturer of Epidiolex, made the announcement on Monday.

“This notification from DEA fully establishes that Epidiolex, the only CBD medicine approved by FDA, is no longer a controlled substance under the federal Controlled Substances Act,” said Justin Gover, GW’s chief executive officer, in a press statement.

Dialling it back

In 2018, Epidiolex 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.

Once approved, the FDA initially placed Epidiolex in Schedule V of the Controlled Substances Act, away from cannabis and its derivatives, which still fall under Schedule I.

Now the drug has been removed from its Schedule V classification, GW Pharmaceuticals intends to “begin the process of implementing these changes at the state level.” Once this process is complete, prescriptions for Epidiolex will become valid for one year and easily transferred between pharmacies.

“We would like to thank DEA for confirming the non-controlled status of this medicine,” Glover continued. “Importantly, the descheduling of Epidiolex has the potential to further ease patient access to this important therapy for patients living with Lennox-Gastaut Syndrome and Dravet syndrome, two of the most debilitating forms of epilepsy.”

Epidiolex, CBD, and epilepsy

Since being approved by the FDA, 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.

The CBD solution was also approved for use in Europe last September and endorsed by the National Health Service in England in November.

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.”