United States approves Epidiolex, first marijuana-derived drug

Henrietta Brewer
June 26, 2018

Regulators at the US Food and Drug Administration today granted market approval for Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD), for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. A study at the end of past year found that almost 70 percent of CBD products sold online were mislabeled. The floodgate effect is known as "sea change", as described by Barbara Carreno, public affairs officer for the U.S. Drug Enforcement Administration (DEA).

For those who have long argued that cannabis offers medical benefits, the FDA approval represents a milestone, "a recognition that the plant is a rich source of compounds which have potential therapeutic activity", Justin Gover, chief executive of GW Pharmaceuticals, the London-based company that developed the drug, said in an interview last week.

"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies".

GW Pharmaceuticals, the British company responsible for the drug, said now approved AEDs (anti-epileptic drugs) are not always effective in the majority of patients with Lennox-Gastaut Syndrome (LGS) and Dravet syndrome - severe forms of childhood-onset epilepsy.


Once the DEA gets the FDA recommendation for how CBD should be scheduled, it has 90 days to decide. "Epidiolex has been studied and proven to significantly reduce seizures so, in a few short months, it will be a new and welcome product for doctors to consider for their patients in need". Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD. But unlike tetrahydrocannabinol, or THC, it does not produce a high.

The Drug Enforcement Administration (DEA) classifies marijuana or cannabis as a Schedule 1 substance - which means there is "no now accepted medical use and a high potential for abuse".

Epidiolex was recommended for approval by an advisory committee in April, and the agency had until this week to make a decision. CBD is one of more than 100 chemicals found in marijuana.

Ohio's medical marijuana program was expected to be operational in early September but now has no definite start date, and none of the approved cultivation centers has begun growing the plant. Epidiolex contains less than 0.1% of THC.


"In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD", Devinsky said.

That's because these kids did not experience as many side effects from the cannabidiol, which can include tiredness, decreased appetite, diarrhea and signs of possible liver damage, Devinsky explained.

The FDA's decision is historic but it is not unexpected.

The FDA previously cracked down on CBD companies for claiming their products could treat cancer and other conditions.


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