FDA approves GW Pharmaceuticals’ CBD drug for new indication

(This story first appeared on Marijuana Business Daily International.)

CBD drug Epidiolex received approval from the U.S. Food and Drug Administration to treat seizures associated with a third medical condition, expanding the range of indications for the cannabis-derived medication.

The orally administered drug from Britain’s GW Pharmaceuticals previously was approved by the FDA to treat seizures associated with two forms of severe epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

The new FDA approval, granted July 31 to GW’s U.S. subsidiary, Greenwich Biosciences, means the drug can now be used in the United States to treat seizures associated with tuberous sclerosis complex, a genetic disease believed to affect one in 6,000 people.

The FDA approved Epidiolex to treat TSC patients 1 year old and up and also expanded the age range for the use of Epidiolex to treat seizures caused by Lennox-Gastaut and Dravet syndromes, lowering the minimum age from 2 years old to 1, GW Pharma said.

“This label expansion, including the expansion of the age range in all approved indications, further demonstrates that the FDA process can continue to enable broader patient access to appropriately tested regulatory approved cannabinoid medicines,” GW Pharma CEO Justin Gover noted in a news release.

The FDA said that, in comparison to a placebo, Epidiolex treatment led to “a significantly greater reduction in the frequency of seizures” in a randomized, double-blind, placebo-controlled trial of 224 TSC patients.

Epidiolex sales comprise the vast majority of GW Pharmaceuticals’ revenue, which was $116.1 million in the company’s most recent quarter.

GW Pharmaceuticals trades as GWPH on the Nasdaq.

2 comments on “FDA approves GW Pharmaceuticals’ CBD drug for new indication
  1. Pat on

    Epidiolex may be FDA approved, but will be out of the reach of many due to its high cost (nearly $32,000/yr). Also, its off label use will be highly restricted, so uses for problems such as nausea and pain control will not be available. Pot, on the other hand, could be virtually free, if all restrictions on its cultivation and use are lifted. But that won’t make capitalists rich, would it? So only a small portion of the population will be able to afford a wildly over-priced drug, thanks to essentially regulatory capture, and Big Pharma can continue to pump big bucks into the campaigns of the very lawmakers that insure this lucrative stranglehold on the market.

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  2. Suzanne on

    Pat you are SO right! Why produce and APPROVE a drug that is so far out of reach for the very people who need it. The FDA on the outside appears to be so “hip” approving a CBD drug… But in fact they are soooo behind the times… as is our government when it comes to NATURAL remedies that could cure more than hurt. There are little to no side effects related to CBD, so there wouldn’t be a big list of warnings or disclaimers at the end of each AD! And YES… money and politics are what drives Pharmacetutical companies to trial and test then the FDA just drags their feet on approving anyway. Instead of moving forward, this country continues to go backwards…in so many ways. It’s sad that there are those who still consider the US a “super power”… superficial perhaps, but far from Super!

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