While the DEA still classifies all other cannabis-derived medicines as Schedule I drugs with no medical value, the agency will have to choose a different schedule for Epidiolex now that the FDA has approved its medical use.
Update: This post has been updated to reflect that the Food and Drug Administration approved Epidiolex on Monday, two days ahead of the deadline. The new drug - Epidiolex is an oral solution made up of cannabidiol (CBD), which is a chemical component derived from marijuana plants that doesn't lead to euphoric high or intoxication. CBD has no psychoactive component to it unlike THC, the other present compound in cannabis. This is the first time the agency has approved a medication with an active ingredient that comes from marijuana.
Now years later, and years happier thanks to her prescription treatment with cannabis-based products, she can understand why others might be more hesitant than she.
The drug is derived from the cannabidiol of cannabis, and, as the plant is yet to be decriminalized by federal regulators, its approval gives GW Pharma a lead among cannabis-exposed companies in the USA financial markets.
Patients, parents of children suffering from severe epilepsy, and some researchers have long suspected CBD's potential to treat the devastating seizure disorders.
An estimated 30,000 children and adults suffer from Lennox-Gastaut syndrome, and fewer from Dravet syndrome.
This drug is a treatment option of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. The ramifications of this approval will be felt far and wide across every sector of the cannabis industry, with GW CEO Justin Gover noting that it could pave the way for further medication approvals.
In particular, Management on control over products and medicines of the US approved a drug called Epidiolex.
A phase three clinical trial is underway for a third seizure-related condition called tuberous sclerosis complex, which begins in infancy and causes a sudden stiffening of the body, arms and legs, with the head bent forward.
FDA's Gottlieb warned about the use of CBD products with "unproven medical claims". Moreover, this is a purified form of CBD. "It's being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits". CBD, as per sources, comprises less than 0.1% tetrahydrocannabinol (THC) that is responsible for intoxicating subjects.
"In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD", said Orrin Devinsky, M.D., of NYU Langone Health's Comprehensive Epilepsy Center. GW won't be able to market Epidiolex until the DEA reclassifies CBD.