FDA Approves Epidiolex

Epidiolex is FDA Approved, Now What Happens?

CBD oil, Cannabidiol, epidiolex

On Monday June 25, 2018, The FDA approved GW Pharmaceuticals’ Epidiolex for treating Dravet Syndrome and Lennox-Gastaut Syndrome.  These two conditions are rare forms of juvenile epilepsy that, until now, were intractable and terminal.  Some of these poor kids have 200-300 seizures a week.  The clinical trials proved that the Epidiolex helped to stop the seizures.  I showed them this 6 years ago, when I started making Halcyon’s version of Epidiolex, but I digress…

What is Epidiolex?

Epidiolex is plant derived cannabidiol (CBD) infused into an oral delivery medium like a seed oil or MCT.  That’s it.  Obviously, its production is clean and exact because they follow GMP and GLP during production, but other than that, Epidiolex is just CBD oil.

They grow high CBD cannabis strains, isolate and extract the cannabidiol, and infuse it into something to swallow.  GW Pharmaceuticals hasn’t modified the CBD molecule or ‘invented’ their own CBD analog.  This is incredibly responsible, and unusual, in the world of Big Pharma.  All medications are based on or inspired by something found in nature – typical sources are elemental minerals, animal venoms, and plant essential oils.  But the drug companies either ‘invent’ a new molecule or modify the existing one.  Their marketing and PR people say the reason is to improve efficacy, but adults know it’s for intellectual property protection.  If you can grow medicine for free, why would you go buy it?  Now, I’m not saying that every patented drug is a money-making ploy and can be substituted by something in nature, I’m simply saying the drug companies are ‘For Profit Companies” that are traded on Wall Street.  So don’t go get bit by a brown recluse to stop buying Xarelto.

GW Pharma has patented the cannabidiol molecule.  This creates a very interesting situation.  I talked to my friend who is an intellectual property (IP) attorney to get his insight on patenting something that easily occurs in nature.  His response is that while it’s a legally shaky patent, it comes down to who has more money to fight with.  This explains why when the DEA reaffirmed its assertion that CBD derived from cannabis was still schedule 1, they sited info from GW Pharma’s people.  GW Pharmaceuticals haven’t invented a new drug, they just got an old one legalized – Still a HUGE deal!

The fact that Epidiolex is simply plant-derived CBD is another reason is received FDA approval unusually fast.  It only took about 4 years to conduct clinical trials, pass all phases of FDA approval, and get a product to market.  This process usually is a minimum of 10 years and $1 billion.

Epidiolex got fast tracked because the data about CBD has been sitting in medical journals for decades.  Doctors and scientists is other countries have been studying the safety and health benefits of CBD for 30 years.  They have known that cannabidiol is non-toxic, non-psychoactive, anti-tumor and anti-inflammatory for decades. The United States is behind in cannabis research because the DEA classifies cannabis as a schedule 1 drug.  This designation means a drug “has high potential for abuse, with no accepted medical use.”  Schedule 2 drugs are drugs that ‘have high potential for abuse, with accepted medical uses.”  The DEA currently says that CBD (schedule 1) is more harmful with fewer(none) medical benefits than coke, meth, morphine, and oxycodone (all schedule 2).

Now that the FDA admits that cannabis, or at least CBD, has medical use, Will the DEA Reschedule?

The short answer is “Yes.”  The bigger question is when and what will it look like?  As mentioned above, cocaine is schedule 2, but that surely doesn’t mean that everyone can buy and sell cocaine.  We know that Big Pharma is looking to protect its money, so I’m not expecting CBD to just become legal.  But regardless of what a reschedule looks like, the FDA approving Epidiolex will force a reschedule.  Here’s why:

We already have prescription THC.  Its called dronabinol.  It’s brand name is Marinol.  It’s been approved by the FDA since 1985.  Many cannabis advocates have argued that dronabinol proves that cannabis has medical use, so it shouldn’t be schedule 1.  I spent hours frustrated with THC being schedule 1 knowing that there were RX analogs of it on the market.  That should prove cannabis has medical uses. The DEA and Courts have remained obstinate to any questioning of a reschedule.

So Why Do I Think that Epidiolex will Force a Reschedule?

Epidiolex is cannabidiol derived directly from cannabis.  Dronabinol (RX THC) is a synthetic copy of THC.  That is the distinction.  The DEA could say that dronabinol is different from THC because one is made from marijuana and the other is made in a lab without marijuana.  Both molecules are identical and work the same way, they are just obtained differently.  It’s like getting pure water from a creek, river, rain, or a chemical reaction – once you isolate and purify it – it’s H20.

Epidiolex is made from marijuana.  There is no synthesis or modification of molecules.  They are just doing what the rest of us who sell CBD have been doing for years…getting good, clean hemp extracts, measuring dosages, and infusing them into products for people.

I believe that we will see CBD carved out of the CSA before we see cannabis and THC moved.  This carve out may be in the form of a hemp bill or just moving cannabidiol, regardless of origin, out of schedule 1 designation.  Either way, some big changes are on the horizon for our industry.

 

By: Daniel Macris

Founder and CEO of Halcyon Organics, Essentials, and Cerebradiol.

Please excuse typos and other mistakes.  I haven’t written this kind of content in a while and I don’t proofread my work or write drafts.  I just channel my t.s. Elliot/will james mode and start writing.  It usually makes sense and has a point 😊

 

Message to my old readers, patients and friends:

I apologize for my and my company’s abrupt disappearance.  There were some fundamentally flawed internal problems that had to be addressed in a very serious way.  I miss all yall and getting ready to relaunch everything.  It’s nice to be developing new products, writing, and following Halcyon’s original vision again!  See everyone soon!

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