In Maryland June 25th, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) CBD oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. Two rare and severe forms of epilepsy.
This is the first FDA approved drug containing cannabidiol (CBD) a derivative of marijuana. Epidiolex is an oral solution for patients two years of age or older.
The two epilepsy forms are severe and associated with high rates of mortality. Some LGS patients have to wear helmets to avoid brain injuries from “drop seizures”, where muscles suddenly become limp and cause standing patients to collapse.
Epidiolex would also be the first approved therapy for DS, treatments for which are currently limited to a combination of seizure medication and drugs to prevent emergencies.
“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”
CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of marijuana.
“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.
The company has not yet set a price for the medication yet and has stated that they will be willing to work with insurance providers to ensure the medicine will be covered in most health plans.
People who support legalizing marijuana say the decision is a step in the right direction, businesses whom rely on the plant must work with the federal government’s ban on its use.
As a result, Epidiolex’s launch remains at the discretion of the DEA, which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, so as to allow GW Pharmaceuticals to begin selling it. GW Pharmaceuticals said it expects the reclassification to occur within 90 days.
WeedShops.com – Where The Grass Is Always Greener