What FDA Approval of GW Pharmaceuticals’ Epidiolex Means for Compassionate Cultivation and Medical Cannabis in Texas

This post, originally published on Feb. 7, 2018, has been updated to reflect the June 25, 2018 news of the FDA approval of GW Pharmaceutical’s CBD drug Epidiolex.


A Statement From Compassionate Cultivation CEO Morris Denton: 

Friends,

It has been widely reported this week that Epidiolex, a cannabidiol (CBD) drug manufactured by London-based GW Pharmaceuticals as treatment for patients with certain types of rare epilepsy, has been approved by the U.S. Food and Drug Administration (FDA) and could be available for sale nationwide in coming months. Naturally, this raises the question of how Compassionate Cultivation and the broader Compassionate Use Act might be impacted when Epidiolex hits Texas markets.

While the natural reaction may be hesitation or perhaps even viewing this as a significant threat, I believe this is a positive development for our business and for our state’s medical cannabis program. With the FDA’s approval of the cannabis-derived drug Epidiolex, this is a strong vote of credibility for the broader medical cannabis and CBD industry.

When produced properly and with the appropriate science, CBD-based medications have real medicinal value—we already know this to be true for patients with intractable epilepsy in Texas. FDA approval of a CBD-based medication not only affirms what the medical cannabis industry has been saying for years about the efficacy of CBD treatments for epilepsy patients, but it also bodes well for expanding Texas’ medical cannabis program. Federal validation of CBD medicine could help sway Texas lawmakers to approve new conditions for medical cannabis treatment in our state.

FDA approval of Epidiolex also opens the door to federal rescheduling of CBD by the Drug Enforcement Administration, which would disentangle CBD from marijuana/THC under federal drug scheduling laws.

The potential state- and federal-level policy implications of Epidiolex approval could be real boons to Compassionate Cultivation’s business. We have the technical ability, the know-how, and all the proper systems in place to produce various formulations of CBD medicine—and we can defend our approach to federal entities. We are also well positioned to expand operations if Texas should approve a broader medical cannabis law.

From a market perspective, I expect the impact of Epidiolex to be fairly contained. There are a few reasons for this.

First, GW Pharmaceuticals sought initial FDA approval of Epidiolex for two specific forms of intractable epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. Many Texas patients with intractable epilepsy who qualify for CBD treatment under the Compassionate Use Act would not qualify for Epidiolex under these indications.

Second, Epidiolex is a singular product made from crystallized CBD, where they completely remove all the other cannabinoids, terpenes and tetrahydrocannabinol (THC) from the end product. While we have the ability to do the same, Compassionate Cultivation’s low-THC, high-CBD formulations enable patients to experience the benefits from the inclusion of THC, which serves as an activation element for the CBD and allows patients to experience the benefits with much lower dosing than what Epidiolex achieves.

Additionally, our advanced extraction processes and rigorous batch testing via flash chromatography allow us to achieve a level of consistency in our products that equals pharmaceutical production, and our test results are publicly available. We are also evaluating the potential of a full-spectrum “CBD Plus” product that would provide the synergistic “entourage effects” and benefits that Epidiolex cannot.

Finally, Epidiolex is initially expected to cost U.S. patients about $2,500 a month. Our CBD-based medications cost just a fraction of that. Even if health insurers agree to cover Epidiolex, it’s unclear how long it would actually take for such coverage to kick in, and many patients are not insured. For uninsured patients, our CBD products are available at a far more affordable price point.

Ultimately, I believe the big-picture implications of the FDA approving a CBD-based medication far outweigh any potential market disruption Epidiolex may cause. While initially focused on CBD-based medicines for the treatment of intractable epilepsy, Compassionate Cultivation’s long-term success is greatly enhanced by any developments that may help expand Texas’ medical cannabis program and lead to the federal rescheduling of CBD.

-Morris

Photo: CEO Morris Denton at Compassionate Cultivation’s Austin-area facility. / Credit: MaggieFitz Photography

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