When the FDA approved the CBD epilepsy medication Epidiolex in June, many wondered whether the DEA would reconsider how it classifies the compound. And today, they got their answer. The Drug Enforcement Administration has rescheduled Epidiolex, making it the first cannabis-based pharmaceutical recognized by the federal agency. The DEA’s decision to reschedule the drug likely won’t trigger any further revisions to the agency’s policy on marijuana. But it does mean that the federal government has finally begun to acknowledge the medical and therapeutic uses of cannabis.
The Drug Enforcement Administration Reschedules GW Pharma’s CBD Drug
Despite legalization in states and territories across the U.S., the federal government is maintaining its strict prohibition of cannabis. And prohibition directly relates to how the DEA classifies the plant. The DEA says marijuana has no medical or therapeutic value and a high potential for abuse. This makes it a Schedule 1 controlled substance, the “worst” of the compounds the DEA categorizes.
The Schedule 1 classification doesn’t just apply to the compounds in cannabis. It applies to the entire marijuana plant. So anything derived from or extracted from that plant, like the cannabinoids THC and CBD, is also illegal. Yet CBD is available widely. Only most CBD products on health store shelves are derived from hemp plants, not cannabis. And earlier this year, the DEA clarified that cannabinoids derived from sources that “fall outside the CSA definition of marijuana,” like hemp, aren’t illegal under federal law.
And that’s what makes the DEA’s decision to reclassify Epidiolex so important. It marks the first time the agency has removed a cannabis-derived substance from the Schedule 1 classification. Making Epidiolex the first cannabis-based pharmaceutical.
Going forward, the DEA will consider the FDA-approved CBD medication Epidiolex a Schedule 5 controlled substance. Schedule 5 substances are those the DEA says have a proven medical use and low potential for abuse. 5 is the lowest level of restricted controlled substances.
DEA’s Decision Applies to Epidiolex Only, Not CBD in General
It’s important to note, however, that the DEA’s reclassification of Epidiolex as Schedule 5 applies to the pharmaceutical only. It does not, in other words, apply to cannabis-derived CBD in general. So for now, Epidiolex isn’t just the first cannabis-based pharmaceutical with FDA approval and DEA recognition, it’s the only one.
The FDA has already approved drugs made with synthetic versions of cannabinoids, such as Marinol, Syndros and Cesamet. But their June decision to approve Epidiolex marked the first time the agency gave the green light to a drug with natural phytocannabinoids.
GW Pharmaceuticals manufactures Epidiolex in the UK. The company describes the drug as a purified form of CBD extracted from cannabis plants with high concentrations of the cannabinoid. The product contains less THC than most CBD oils, with just 0.1 percent THC. GW Pharma designed the drug to treat severe forms of epilepsy that occur in children with Lennox-Gastaut and Dravet syndromes. After successful clinical trials, the company sought FDA approval for Epidiolex.
Patients take the CBD drug as a strawberry-flavored oral spray. It does not produce any psychoactive side-effects. And the DEA reclassification along with the FDA approval is good news for patients pocketbooks. No longer restricted under federal law, patients can now receive insurance coverage for the cost of Epidiolex.