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

 In Blog, Compassionate Cultivation, Info on CBD, Legislation

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

A Statement From Compassionate Cultivation CEO Morris Denton on the Anticipated FDA Approval of GW Pharma’s CBD Drug Epidiolex

Friends,

You may have seen reports that Epidiolex, a cannabidiol (CBD) drug manufactured by London-based GW Pharmaceuticals as treatment for patients with certain types of rare epilepsy, could win approval from the U.S. Food and Drug Administration (FDA) this summer and may be available for sale nationwide as soon as this fall. Naturally, this raises the question of how Compassionate Cultivation and the broader Compassionate Use Act might be impacted if Epidiolex hits Texas markets.

While the natural reaction may be hesitation or perhaps even viewing this as a significant threat, I believe this would be a positive development for our business and for our state’s medical cannabis program. If the FDA approves a CBD-based medication like Epidiolex, it would be 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 would not only affirm what the medical cannabis industry has been saying for years about the efficacy of CBD treatments for epilepsy patients, but it would also bode 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 could also open the door to potential federal rescheduling of CBD, potentially disentangling 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 non-THC 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 is seeking 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 products enable patients to experience benefits from the synergistic “entourage effect” that isn’t possible with a single-cannabinoid formulation. 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 THC-free “CBD Pure” product that would provide full-spectrum 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 that 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 or lead to the federal rescheduling of CBD.

-Morris

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Comments
  • Jim deVault
    Reply

    All the FDA has done, as far as anti-seizure drugs are concerned is approve drugs like Keppra, which does no more than raise the seizure threshold and poison the body. The FDA is rushing to get something approved cause those of us with epilepsy could care less what the FDA does to support their bed partner Big Pharm. Secondly, they have to act quickly after a Federal Judge took the governments anti marijuana arguments to task yesterday and because London, Spain and Portugal are way ahead of the US in uses for medical marijuana and having success.

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