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Epidiolex: What it is-- and What it Means for the Future of CBD

April Morris

Posted on November 05 2018

Epidiolex: What it is-- and What it Means for the Future of CBD
Will a new cannabinoid-based drug pave the way for more CBD-based therapeutic products? Let’s find out.

What is Epidiolex?

Epidiolex is an oral solution medicine, plant-derived from Cannabidiol (CBD). It’s used in the treatment of severe forms of epilepsy — primarily Dravet syndrome and Lennox-Gastaut syndrome, two of the rarest forms of epilepsy — in patients 2 years of age or older (1).

GW Pharmaceuticals conducted three placebo-controlled, double-blind trials in patients with Dravet syndrome and Lennox-Gastaut syndrome. The results from these trials demonstrated a considerable amount of evidence of the safety and effectiveness in decreasing the regularity of seizures in patients (5).

This, however, isn’t the first time we’ve heard of CBD effectively decreasing seizures in patients.

At 3 months old, Charlotte Keating started developing seizures on a regular basis. Through rigorous testing and research, doctors were able to diagnose her with Dravet syndrome – a rare but severe form of epilepsy that cannot be controlled by her prescribed medications. Though medication helped for a short time, Charlotte began seizing again, averaging 300 seizures a week.

Hopeless and desperate, her parents sought alternative treatments for Charlotte. They came across CBD and the results were astonishing. With the use of CBD treatment, Charlotte went from 300 seizures a week to 1-2 seizures a month. Today, Charlotte lives a more normal life and her parents couldn’t be more relieved (4).

It was only a matter of time before the FDA would approve of this treatment, as the evidence alone supported the safety and effectiveness in GW Pharmaceuticals trials.

The first FDA approved, synthetic-free, cannabinoid-based drug
In receiving Orphan Drug Status and Fast Track classification, Epidiolex is the fourth FDA approved drug derived from marijuana, the first three being:
● Liquid synthetic THC (Syndros)
● Dronabinol (Marinol)
● Nabilone (Cesamet)

However, the difference in Epidiolex is that it’s a purified drug that contains plant-derived cannabinoids, thus being the first FDA-approved, cannabis-based drug that’s free from synthetic substances (3).

This is also the first FDA drug approved for the treatment of Dravet syndrome. FDA Commissioner Scott Gottlieb, M.D. says, “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes (1).”

What this means for the future of CBD

As of today, CBD is still classified as a Schedule I controlled substance. But, with the FDA’s approval of Epidiolex, could this be a step in the right direction for CBD and its federal legalization?

According to Deputy Director Paul Armentano, it’s “unclear whether the scheduling of Epidiolex per se will have any tangible impact on the scheduling of CBD."

However, because Epidiolex is plant-derived from marijuana and free of any synthetic substances, Deputy Director Paul Armentano anticipates that with the FDA’s approval, Epidiolex may move from a Schedule I to a Schedule III classification. That’s “if the DEA is compelled to revisit the issue of CBD scheduling," says Deputy Director Paul Armentano (2).

Examples of Schedule III drugs include:
● Tylenol with Codeine
● Buprenorphine (Suboxone)
● Benzphetamine (Didrex)
● Phendimetrazine
● Ketamine
● Anabolic Steroids such as Depo-Testosterone (6)

This, unfortunately, does not include any products that contain CBD that have not been approved. Unapproved products that contain CBD will stand as a Schedule I classification. FDA Commissioner Scott Gottlieb affirms: “This is the approval of one specific CBD medication for a specific use. This is not an approval of marijuana or all of its components (3).” And of course, hemp is also still classified under Schedule I.

What’s ahead for CBD and Hemp
In the end, it’s hard to deny the evidence we are seeing from CBD treatment. With Epidiolex being the first FDA-approved, synthetic-free, cannabis-derived drug, it’s definitely a step in the right direction for more therapeutic cannabinoid-based treatments to come to market. Hopefully this will also lead to Congress passing the Hemp Farming Act, which would permanently establish hemp and hemp-derived products as agricultural commodities, thus no longer classifying them as controlled substances.


By: Joy Hughes

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