Epidiolex And its Impact Over the Coming Months

The Cannabis derived product Epidiolex, produced by GW Pharmaceuticals, was just approved by the United States Food and Drug Administration for the treatment of Lennox-Gastaut syndrome and Dravet syndrome—which are both rare forms of epilepsy. For the first time since its prohibition, a product truly derived from Cannabis has been recognized to have medical application in the United States.

In the published study found here and in the final report delivered to the FDA found here Epidiolex was shown to reduce seizures by around 40%. This is an immense step in the direction of Cannabis based medical applications, even acknowledging some of the side effects which included, most significantly, elevated liver enzymes.

One of the main questions that's begun to surface is: since Cannabis, or marijuana as it’s listed, is on the Controlled Substances Act, how is reclassification going to look? GW Pharmaceuticals derives the CBD in their products from a proprietary strain of Cannabis. (CBD, unlike THC, is non-psychoactive) While their strains are lower in THC than many traditional recreational Cannabis strains, they technically wouldn't be able to exceed 0.03% of THC. This is the allowable limit for a classification of hemp, which still can't be produced commercially because of the 2014 Farm Bill. So, how might this new system take shape?

(Getty Images)

“Marijuana and its cannabinoids” are listed under Schedule I of the Controlled Substances Act, giving them no recognized medical value and a high potential for abuse. Since CBD, now recognized at least in the form of Epidiolex by the FDA, will need to be reclassified by the DEA, will that mean the entire plant itself will need to be re-evaluated also? Or will there be an incremental approach taken to insist that while marijuana and a majority of its cannabinoids are still illegal, CBD remains the exception?

What then, you might ask, would happen with cannabigerol (CBG)? If you're not familiar, this is the chemical precursor to CBD, but recognized as an independent cannabinoid. It also happens to be the precursor to THC-- you know, the psychoactive one. Or how about CBC, for that matter? What will become of it? Non-psychoactive but still its own cannabinoid, and one with astounding medical potential already being studied by GW Pharmaceuticals as well.

Oh, and what about the cannabinoids that might exist that we don’t know about yet? Acidic forms of chemical catalysts yet undiscovered? Are we going to have to go through this process all over again? Rather, is some other conglomerate or just this same one going to buy its way into full and exclusive access to cultivate the only recognized "legal" forms of Cannabis?

It stands to reason that our new classification might rule that Cannabis cultivated above the level of THC produced by GW's proprietary genetics would remain scheduled as illegal. This would mean that the entire description of marijuana would need to change within the framework of a Schedule I status, or that simply CBD alone would need either reclassified or declassified altogether. But again, Cannabis and its cannabinoids aren't that cut and dry, something we should hope is going through the minds of those in control at the DEA.

The next three months occupy the projected time GW Pharma has for the DEA to reschedule CBD. That time will be well spent as both arms of a governmental body reconcile with what has become a most convoluted conversation that crosses many facets of our nation's history, all surrounding this plant. There could be major implications for the existing Cannabis industry if every aspect of the plant is re-evaluated. We could also face just another incremental approach while many of those involved align their financial interests correctly. We should pay close attention to what comes out of the DEA's next line of decisions. Whether you're dabbing some fine THCA crystalline every day or you've never encountered Cannabis physically, the war on this plant has affected everyone in this country in some way. The FDA has stirred our interpretation of Cannabis hopefully for the better. I will be holding my breath, along with some CBD dominant weed.

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