Today the U.S. Food and Drug Administration (FDA) approved Epidiolex for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, making it the first-ever cannabis-derived drug to be approved by the organization, and also the first drug approved for Dravet syndrome.
“This is the first FDA-approved drug that contains a purified drug substance derived from marijuana, the organization wrote in a press release. “It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.” While the FDA has approved synthetic cannabinoid solutions such as Marinol or Cesamet since 1985, this is the first time a drug derived from cannabis has been approved.
Epidiolex contains CBD and was likely approved because it causes no intoxication. But while CBD causes no intoxication, it can potentially help fight seizure disorders that are considered incurable and treatment-resistant.
Dravet syndrome, a rare genetic disorder that causes seizures, is considered incurable. Recently, families all over the world have been noticing CBD’s incredible anti-epileptic abilities, and the overly bureaucratic pharmaceutical industry is just starting to catch up. Dravet syndrome and Lennox-Gastaut, as mentioned in the press release, are difficult to control, and require new and developing treatment routes such as medical cannabis.
“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. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D.
Breaking News: @US_FDA Approves GW Pharma’s #Cannabis-Derived Epidiolex to Treat Epilepsy.@DEAHQ now has 90 days to reschedule CBD following which all CBD manufacturers in the U.S “have to be registered with them”. according to a quote from a @DEAHQ public affairs officer.
— Deepak Anand ? (@_deepakanand) June 25, 2018
Many have been speculating what the approval means for CBD vendors, if anything. While this is certainly great news for the British drug-maker GW Pharmaceuticals, which will be making a lot of money off of Epidiolex, it’s even greater news for the families who rely on CBD-based medicine.