A new drug derived from marijuana just became the first of its kind to get the green light from the US government.
Called Epidiolex, the drug is designed to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD).
The federal thumbs-up comes on the heels of several months of promising research results and a positive preliminary vote from the Food and Drug Administration this spring. Experts are hopeful that the approval will unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds.
“This approval serves as a reminder,” Scott Gottlieb, the FDA commissioner, said in a statement on Monday, “that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.”
In three large clinical trials which the FDA considered before giving Epidiolex the official green light, researchers presented strong evidence that the pharmaceutical-grade CBD in the medicine had the power to significantly curb some of the worst symptoms of two of the hardest-to-treat forms of epilepsy, known as Lennox-Gastaut syndrome and Dravet syndrome.
“This is clearly a breakthrough drug for an awful disease,” John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug.
But although the green light means that patients will soon be able to access Epidiolex with a doctor’s prescription, many will also likely turn to less expensive sources of CBD, such as those sold in marijuana dispensaries. Researchers and advocates cautioned against this, however, with the caveat that it’s impossible to verify that what’s in those products is actually pharmaceutical-grade CBD
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