Could a Cannabis-Based Drug Affect the CBD Industry?
A cannabis-derived drug moved one step closer to approval in the U.S. earlier this year.
The advisory committee to the Food and Drug Administration unanimously voted to recommend the approval of Epidiolex, a CBD-based product, for the treatment of rare and severe forms of epilepsy.
Epidiolex is essentially a pharmaceutical-grade version of cannabidiol, or CBD oil. CBD is one of more than 100 chemical compounds found in the cannabis plant. Unlike THC, the compound in marijuana that produces a high when consumed, CBD doesn’t produce any mind-altering effects.
Developed by British company GW Pharmaceuticals, the syrup-like oral medicine is unlike anything currently available in the U.S.
Speaking to NBC News, Dr. Orrin Devinsky, director of NYU Langone Epilepsy Center said, “This is not something you can get from a dispensary today in the United States. It’s not something that you can get by smoking marijuana. It is a very specific pharmaceutical grade product derived from marijuana, but quite different than what is available anywhere else right now in the United States.”
The FDA is expected to complete its review process of Epidiolex by the end of June. If approved, GW Pharmaceuticals’ cannabidiol medicine would become the first drug derived from the cannabis plant to win FDA approval in the U.S.
Is CBD a Controlled Substance?
Although more than 20 states allow the use of medical cannabis, the Drug Enforcement Administration still classifies marijuana as a Schedule I controlled substance, meaning it has “no currently accepted medical use and a high potential for abuse.”
However, since CBD isn’t considered a scheduled substance in its own right, the DEA can schedule it differently from cannabis itself.
If Epidiolex is approved, GW Pharmaceuticals expects the drug to be classed as Schedule IV, which is the same category that many sleep and pain medications fall under.
CBD Products Experience Increased Growth
CBD oil is currently available online, in health shops, and specialty shops across the U.S. Majority of states allow its use, but CBD does not have FDA approval. Despite the fact that these supplements are largely unregulated, the CBD industry is growing rapidly.
According to analytics firm New Frontier Data, CBD sales are predicted to quadruple over the next four years, from $535 million in 2018 to over $1.9 billion by 2022.
Approval of Epidiolex Could Affect the Sale of CBD Products
With a wide range of healing properties, consumers are turning to CBD for a variety of conditions, including anxiety, insomnia, depression, and pain.
According to a study by Brightfield Group and HelloMD, only 2% of survey respondents used CBD to treat epilepsy.
Since Epidiolex would be prescribed only for patients suffering from Lennox-Gastaut syndrome and Dravet syndrome, the drug likely won’t affect the availability of products already on the market.
Bethany Gomez, Director of Research at Brightfield Group, predicts limited impact for current CBD retailers:
“The majority of sales are conducted either online, sold to customers in prohibition states or both. The ease and discretion of access for patients is a key selling point for hemp-derived CBD, and why existing products will not face significant competition from an expensive, highly regulated and narrowly prescribed product like Epidiolex in the immediate term.”
GW Pharmaceuticals claim their objective is simply to provide patients with a regulated and research-backed CBD alternative.
“We’re not looking to impact the availability of other products on the market,” GW executive Steve Schultz told The Washington Post. “Our goal is to provide an additional option for patients and physicians who desire a purified version of CBD for treatment of seizures.”
So What Does This Mean For the CBD Industry
The pending FDA approval of Epidiolex will help to raise interest and awareness around CBD’s safety and efficacy – and this could have a profound effect on the industry as a whole.
It’s likely this breakthrough drug will act as a catalyst for further research and development of FDA-approved cannabis products and add to the burgeoning market of CBD products.
Not only will the U.S. market be impacted, but the international CBD market as well.
There’s no doubt this is a win for those who might benefit from Epidiolex, and for everyone who loves and uses CBD.
Alan Brochstein, a founding partner at New Cannabis Ventures, predicts we’re one step closer to seeing CBD-derived drugs on pharmacy shelves:
“The bottom-line, then, is that approval of Epidiolex is likely to be a boon for patients suffering from epilepsy and to open the door to a pharmaceutical distribution pathway for cannabis-derived drugs, but it is also likely to drive significant interest in the broader CBD category.
In the same way that the over-the-counter fish-oil market has thrived more than a decade after the introduction of prescription-strength products, the CBD market is likely to see significant expansion in the coming years.”
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