The Food and Drug Administration made history on Monday by approving the nation’s very first drug derived from cannabis called Epidiolex.
GW Pharmaceutical’s Epidiolex is made of CBD, a component of marijuana that provides no high effect.
The medicine has been shown to reduce the amount of seizures by roughly 40% in patients who have Lennox-Gastaut syndrome and Dravet syndrome, two severe forms of epilepsy.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” said FDA Commissioner Scott Gottlieb.
He added, “And, the FDA is committed to this kind of careful scientific research and drug development.”
The next step is for the Drug Enforcement Administration to reclassify cannabidiol before GW Pharma can sell Epidiolex.
“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 also said.
“However, we remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims.”
Disclaimer: We have no position in GW Pharmaceuticals (NASDAQ: GWPH) and have not been compensated for this article.