WASHINGTON, DC — Epidiolex, a prescription medicine containing a standardized formulation of the plant-derived cannabidiol (CBD), is now available in pharmacies in all 50 states.
The US Food and Drug Administration approved the product in June for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.
In September, the US Drug Enforcement Administration reclassified it from Schedule I to Schedule V— the lowest restriction classification available under federal law. Physicians, at their discretion, may also elect to prescribe the medicine “off-label” for medical conditions other than epilepsy.
An annual prescription for Epidiolex is estimated to cost $32,500 per year, a price that the manufacturer says is “in line with other FDA-approved anti-epileptic drugs.”
Epidiolex is the fourth marijuana-based medicine to receive FDA approval — joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros).
However, Epidiolex is the first FDA-approved medicine containing plant-derived non-synthetic cannabinoids.
Tags: cannabidiol (CBD), cannabiniol, CBD, Dravet syndrome, Epidiolex, epilepsy, extracts, FDA, FDA approval, Food and Drug Administration, GW Pharmaceuticals, Lennox-Gastaut syndrome