DEA Removes Epidiolex From Controlled Substances List

The U.S. Drug Enforcement Administration has removed the CBD pharmaceutical Epidiolex from the nation’s list of controlled substances, a move that should make it easier for patients to access the medication. Epidiolex is the only medication derived directly from cannabis that has been approved by the U.S. Food and Drug Administration for use in the United States.

The drug 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. Epidiolex is produced by drug manufacturer GW Pharmaceutical at its facilities in the U.K.

After Epidiolex received FDA approval in June 2018, the drug was placed on Schedule V of the Controlled Substances Act (CSA). On Monday, GW was notified by the FDA that the drug is longer subject to the CSA, a change that goes into effect immediately.

“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 GW CEO Justin Gover in a press release.  “We would like to thank DEA for confirming the non-controlled status of this medicine. 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.”

Easing Access For Patients

William Roark, the co-chair of the Pennsylvania Bar Association’s Medical Marijuana and Hemp Law Committee, said that removing Epidiolex from the CSA will make the drug more accessible to patients.

“It means doctors don’t have to go through the drug-monitoring program to make certain their patients don’t have a drug history,” he told the Philadelphia Inquirer. “And a parent will now be able to go from pharmacy to pharmacy rather than having one specific source.”

Although Epidiolex has only been approved by the FDA to treat Dravet syndrome and LGS, the so-called off-label use of drugs for other conditions is legal and a common practice with other medications. The price of the drug may be prohibitive for some patients that need it, however. In 2018, GW announced that the average annual cost of Epidiolex would come to about $32,500 per year, although most patients with health insurance would pay a fraction of that figure.

GW is also seeking approval from the FDA for Epidiolex to be used as a treatment for seizures associated with another disease, tuberous sclerosis complex.