Please ensure Javascript is enabled for purposes of website accessibility

The DEA Has Descheduled Prescription CBD for Severe Epilepsy

By Cory Renauer - Apr 6, 2020 at 1:30PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

Marketing Epidiolex is about to get a lot easier for GW Pharmaceuticals.

Parents of children with early-onset epilepsy and their physicians will find it easier to fill their next Epidiolex prescriptions. That's because the CBD tincture from GW Pharmaceuticals (GWPH) is no longer under the thumb of the Drug Enforcement Agency (DEA). 

Non-controlled status 

Epidiolex launched in 2018 after earning FDA approval as a treatment to reduce seizure frequency for patients with Lennox-Gastout syndrome and Dravet syndrome -- a small population. The 2018 Farm Bill removed hemp-derived CBD from the definition of marijuana in the Controlled Substances Act (CSA), but that didn't do much to help GW Pharmaceuticals. Epidiolex's active ingredient is CBD derived from marijuana, not hemp.

Cannabidiol under a hand lens.

Image source: Getty Images.

The DEA placed Epidiolex in Schedule V, the least restrictive rating a drug can receive under the CSA, but there were still plenty of restrictions. Effective immediately, prescriptions for Epidiolex will be valid for an entire year and can be easily transferred between pharmacies.

Another banner year ahead

In 2019's fourth quarter, sales of Epidiolex climbed to an annualized $436 million, and sales of the CBD tincture will probably climb much further in 2020. In addition to relaxed restrictions, GW Pharmaceuticals could get a helping hand from the FDA later this year.

At the end of March, the FDA began reviewing a supplemental application that would expand the drug's addressable patient population to include patients with tuberous sclerosis complex -- another serious childhood disease that leads to uncontrolled seizures.

The FDA is expected to announce its decision on that application on or before July 3.

Cory Renauer has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

GW Pharmaceuticals plc Stock Quote
GW Pharmaceuticals plc

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
S&P 500 Returns

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 08/17/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.