FDA panel unanimously votes for GW Pharma's cannabis-derived epilepsy drug

Wikimedia Commons

Wikimedia Commons

But in documents this week, FDA officials wrote they supported the approval of the drug, Epidiolex, after concluding that it cut the number of seizures in patients in clinical trials.

"It's an incredible signal and further validation of the future potential of cannabinoid based therapeutics", Azadian said of the FDA panel vote.

"The safety concerns could be managed with labeling and monitoring", said Jane Acri, a panel member who works in medication development at the National Institute on Drug Abuse.

In sometimes emotional testimony, the parents of children with the conditions urged the panel and FDA to get the drug to the market. Doctors at Children's Colorado don't prescribe medical marijuana though they will care for children who use it. But since Olivia began taking Epidiolex in 2014, her mother said, there have been "great improvements", including many days when she did not have any seizures at all. But experts have said that having an approved and regulated medication available in a standard dose is important because self-treating can expose patients to irregular doses, substandard supplies, or the risk of side effects without medical oversight.

While the cannabis plant is used to produce Epidiolex, the medicine is derived from CBD, a non-psychoactive component found in marijuana that is legal in all 50 states and contains less than 0.1-percent THC - the psychoactive component in weed that makes users feel "high".

GW Pharmaceuticals offered "substantial evidence" to back Epidiolex's effectiveness, according to the FDA panel's report.

"CBD is now a Schedule I drug", the FDA notes, while simultaneously admitting, in a memo attached as an appendix, that "CBD does not appear to have abuse potential".

This will change eventually and, possibly, sooner rather than later, after the federal Food and Drug Administration on Tuesday gave a positive recommendation for CBD-based drug created to treat children with severe epilepsy. And it could pave the way for other cannabis-based drugs, analysts say.

If approved, the drug would be noteworthy for being the first in a new category of epilepsy treatments, as well as for being the country's first cannabis-derived drug.

Shares of GW Pharmaceuticals did not surge much on the news, as the market had already anticipated a decision and traded on speculation, with the stock gaining more than 5.6 percent since Monday.

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