FDA Could Soon Approve 1st Drug Extracted From Marijuana

It would treat a severe form of epilepsy in children
By Michael Harthorne,  Newser Staff
Posted Mar 15, 2016 5:25 PM CDT
FDA Could Soon Approve 1st Drug Extracted From Marijuana

The FDA could soon approve a marijuana-derived drug to treat a severe form of epilepsy in children, the New York Times reports. It would be the first-ever drug extracted from marijuana to be approved for use in the US. Epidiolex utilizes the active ingredient cannabidiol to treat Dravet's syndrome, according to the Wall Street Journal. Children who took part in a recent trial were averaging about 13 convulsive seizures every month despite being on approximately three other medications each. Epidiolex reduced the frequency of their seizures by 39%. The CEO of GW Pharmaceuticals, which makes Epidiolex, says the trial "validates the proposition that cannabinoids can play a meaningful role in modern medicine.”

Up to 30% of children with epilepsy are not helped by current drugs, and there is no treatment available specifically for Dravet's syndrome. GW Pharmaceuticals plans to file for approval with the FDA following the success of its Epidiolex trial, and the Times states its approval "could lend credence to the medical marijuana movement." More and more parents are are already trying extracts from medical marijuana dispensaries to help their epileptic children, reporting strong results using a non-FDA approved extract known as Charlotte's Web. “I would strongly advocate that in the United States we need to do systematic assessments of medical marijuana,” the Epidiolex trial's lead investigator tells the Times. The FDA has already approved two drugs that use synthetic versions of THC, another component of marijuana, to treat patients with AIDS or undergoing chemo. (More medical marijuana stories.)

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