Cannabis Medicine To Treat Epilepsy Officially Approved By FDA

Norman Posselt—Getty Images  fStop

Norman Posselt—Getty Images fStop

Regulators at the US Food and Drug Administration today granted market approval for Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD), for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. The drug will be marketed under the brand name Epidiolex.

While Epidiolex is the first approved medicine that comes from a pot plant, the FDA has allowed the use a few drugs made from synthetic cannabinoids, including Insys Therapeutics Inc's Syndros for loss of appetite in people with AIDS and nausea caused by chemotherapy.

Although CBD is now classified as a Schedule I substance, the FDA found in its review of the medication that its potential for abuse is low.

"The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels", FDA Commissioner Scott Gottlieb said in a Monday press release.

The two epilepsy forms are severe and associated with high rates of mortality.

"Moreover, this is a purified form of CBD", Gottlieb continued. But CBD products available in retail stores can have unreliable concentrations or poor quality controls. There was some concern about the drug's effects on the liver, but experts have said this risk could be addressed by doctors as they monitor their patients during treatment. "We can't guarantee the consistency".

Epidiolex won't require a special certification to prescribe, Patel said, and it's likely physicians will prescribe it for off-label uses. "I'm always excited about the potential for a new therapy that has been well-studied and has a great potential for benefit", he says.

The FDA previously cracked down on CBD companies for claiming their products could treat cancer and other conditions. And Epidiolex could well be the first in a wave of marijuana-based therapies; agency officials said they have implemented regulatory processes to help drug developers test marijuana or its components in their own clinical trials.

The company has not said how much the drug will cost, but Wall Street analysts have predicted it could cost $25,000 per year. However, the FDA has found that Epidiolex, when combined with other medications for epilepsy, does reduce seizures.

Although legal to possess in some U.S. states, cannabis is now listed under Schedule 1 of the USA federal government's Controlled Substances Act, which is reserved for drugs that are considered to have "no now accepted medical use and a high potential for abuse".

This one landmark approval could have another one following it soon: the reclassification of CBD by the United States Drug Enforcement Administration.

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