Epidiolex is Close to FDA Approval

UPDATE: Epidiolex Approved. In June 2018, Epidiolex became the first cannabis drug approved by the FDA. Read the article below to know what happened leading up to approval.  

What will Epidiolex’s FDA Approval mean for the CBD Industry?

After an advisory panel to the US Food and Drug Administration (FDA) gave unanimous support for the approval of Epidiolex, it appears the drug is on its way to becoming the first FDA-approved cannabis medication in the United States. But what does that mean and in particular, what does it mean for the CBD industry as a whole?

Epidiolex’s Road to FDA Approval

Epidiolex is a CBD isolate created by British company GW Pharmaceuticals. The pharmaceutical company started initial trials for the drug in September 2013. A few months later in May 2014, the company received approval for their IND (Investigational New Drug Application) that they filed with the FDA. This allowed the company to begin human trials using Epidiolex. A series of trials regarding the use of Epidiolex for Lennox-Gastaurt Syndrome and Dravet Syndrome took place over the next few years.

The results of these trials made it possible for GW Pharmaceuticals to successfully submitted their NDA filing (new drug application) to the FDA in December 2017.

April 2018, an external advisory panel to the FDA recommended the drug be approved for treating patients with Lennox-Gastaurt Syndrome & Dravet Syndrome. The approve is likely to go through the FDA by June or July 2018.

dravet syndrome facts cbd

Epidiolex Approved for Two Specific Uses

GW Pharmaceuticals’ drug is only being considered for two types of epilepsy, both which are relatively rare. Of course, doctors are legally allowed to prescribe any drug for what is known as “off-label” uses (something other than what the label states the drug is intended to be used for).

One reason doctors don’t do this very often is that insurance companies don’t always cover off-label prescriptions (or at least not to the extent that they would for label-use prescriptions).

Without insurance, Epidiolex will cost a patient between $2,500-5,000 per month.

Epidiolex vs. CBD Supplements on the Market

As mentioned, Epidiolex is a CBD isolate. This means CBD has been extracted from the hemp plant, and the drug is pure CBD and nothing else.

Right now there are two types of CBD supplements on the market: isolate and full-spectrum (whole plant).

Full-spectrum CBD, however, benefits from the whole plant. As a result, it promotes an “entourage effect”. The hemp plant contains more than 400 natural cannabinoids and terpenes. Full-spectrum advocates believe that CBD works better alongside these natural components rather than isolated from them.

Right now it’s not too clear how Epidiolex’s potential FDA-approval will impact the CBD supplement market. If Epdiolex gets classified as a drug can CBD still be a supplement? While it sounds like a legitimate concern there’s no need to panic just yet. It’s highly unlikely that  Epidiolex will push CBD supplements into oblivion. Not entirely, anyway. Here’s what seems like a likely outcome: existing CBD isolate supplements may be in danger (since Epidiolex is an isolate) whereas full-spectrum CBD supplements will not. As a result, a lot of CBD isolate companies may pivot into full-spectrum CBD companies in order to stay in business and away from legal problems.

Remember, this is just our hypothesis. Perhaps even CBD isolate products will still be able to coexist alongside a prescribed CBD medication. We’ll have to just wait to find out.

We’ll be posting regular updates on CBD and the FDA as it unfolds, so keep checking back for the latest news.

For more reading check out the New York Times article.

Epidiolex is not the only Cannabis Drug by Big Pharma

Epidiolex is not the only cannabis medication seeking FDA approval. INSYS Therapeutics had their THC drug Syndros approved by the FDA in the fall of 2017. There is one noticeable difference between the two pharmaceuticals, however. Epidiolex is botanical CBD whereas Syndros is a synthetic THC. This is important when considering how each pharmaceutical will impact unregulated marijuana/cannabis industries.

different types of CBD full spectrum vs isolate

Colorado Passes Bill to Allow Doctors to Prescribe Epidiolex

Hemp Legalization in Congress - epidiolexIn April, Colorado passed House Bill 1187. Under this bill, Colorado doctors can prescribe Epidiolex the minute it gets FDA approval. While the DEA’s recent statement on CBD makes this bill unnecessary, it’s important to note this bill states:

Specifically, the general assembly does not intend for this legislation to be construed so as to prohibit, preclude, or otherwise affect previously authorized activities concerning products derived from marijuana, industrial hemp, or other lawful sources which contain cannabinoids but which are not a prescription medicine approved by the United States food and drug administration.

Being that a subsidiary of GW Pharmaceuticals, Greenwich Biosciences, was the primary backer of the bill, we can only assume they agree with this statement, and will not push to ban CBD supplements.

We’ll be posting regular updates on Epidiolex and the CBD industry as they unfold. Keep checking back for the latest news.