In what’s sure to be a day for the history books, the FDA has officially released its long-awaited decision on Epidiolex, the CBD medicine for treating epilepsy.
The U.S. Food and Drug Administration has approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with two forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome.
The drug has been approved for patients two years of age and older.
In addition to being the first FDA-approved drug that contains a purified component of a marijuana plant, this is also the first FDA-approved drug for the treatment of Dravet syndrome.
Both Lennox-Gestaut and Dravet syndrome are rare forms of childhood epilepsy and are problematic because they are treatment resistant.
For the drugs that do work for these syndromes, the side effects are often just as bad or even worse than the syndromes themselves.
Epidiolex, made by GW Pharmaceuticals, was approved after its effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving over 500 patients.
One of the most cited of these studies resulted in 43% of patients cutting their seizure frequency in half.
While CBD is generally recognized as safe and without risk of fatal overdose, medical supervision is necessary.
Drug interactions are possible.
The most common side effects in the Epidiolex clinical trials were: decreased appetite, sleepiness, sedation, lethargy, elevated liver enzymes, diarrhea, rash, fatigue, malaise, weakness, insomnia, sleep disturbances, and infections.
Despite the list of possible side effects, the FDA’s approval of a CBD based medicine is a major step forward for medical cannabis.
FDA Commissioner Scott Gotlieb shared his optimism of future approval of research-backed uses of cannabis-derived medicines.
Adequate and well-controlled clinical studies helped lead to FDA’s approval of the first CBD drug product. FDA actively supports drug developers wanting to investigate marijuana or its components for potentially safe and effective medical uses https://t.co/sIlQaZtzsY
— Scott Gottlieb, M.D. (@SGottliebFDA) June 25, 2018
What does the FDA approval of Epidiolex mean for the CBD industry?
While many are excited by the FDA’s move since people will now have legal access to Epidiolex, some proponents of CBD have also shared their concerns.
The biggest fear seems to be that this will destroy the artisanal and nutraceutical CBD industry which has been operating on shaky ground since the 2014 Farm Bill made it legal to grow hemp for research purposes.
The FDA has made it clear that it will continue to go after CBD sellers making medical claims or selling mislabeled products.
It also still remains to be seen how cannabidiol will be scheduled now that it is an FDA approved drug.
While nothing is certain yet, we at CBD School do not see the approval of Epidiolex to be a threat to the CBD industry.
We welcome its approval as it will bring more credibility and regulation to space.
Is Epidiolex the same as CBD oil?
You may have noticed that Epidiolex is described as a purified version of CBD.
This is another way of saying it is a CBD isolate, made by extracting CBD from cannabis plants and then separating it from the many other compounds naturally found in cannabis extracts.
Epidiolex is unique in that it’s a plant based drug.
Most pharmaceuticals, including the other FDA, approved cannabis-like drug Marinol, are synthetic compounds made in a lab to mimic active ingredients in plants like cannabis.
Marinol is a synthetic version of THC, the drug in marijuana responsible for its psychoactive effects.
The FDA and drug companies have a preference for working with synthetic, single compound drugs because they are considered to be easier to dose and more predictable in treatment.
From a business perspective, they’re also patentable.
Epidiolex is unique because it’s sort of in-between a botanical supplement and a single molecule drug.
The CBD in Epidiolex is extracted from cannabis plants.
But for the sake of creating a consistent product, the CBD is stripped away from all of the other components naturally found in cannabis extractions.
These components which include terpenes, flavonoids, and antioxidants have long been touted to be significant contributors to the therapeutic effects of cannabis — a phenomenon known as the entourage effect.
It’s precisely due to this entourage effect, and the widespread demand for it among the cannabis community, which led us to conclude that Epidiolex poses no threat to the CBD industry.
When consumers buy CBD oil derived from either marijuana or hemp, they’re seeking out a product that gives them more than just CBD.
They’re seeking the other minor cannabinoids, terpenes, and flavonoids naturally found in cannabis plants. They’re seeking the entourage effect.
And this is precisely why we believe both nutraceutical CBD products and prescription based Epidiolex will coexist and thrive together.
This is not a zero-sum game.
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