FDA Approves Groundbreaking Drug for Treating Rare, Severe Forms of Epilepsy – APhA submits compounding comments to FDA. – (866) 348-2889.
Officials with the FDA have approved a novel cannabidiol (CBD) treatment for 2 rare and severe forms of epilepsy, making it the first FDA-approved medication that contains a purified drug substance derived from marijuana, according to a press release.1 Epidiolex (GW Research) is an oral solution indicated to treat seizures associated with Lennox-Gastaut syndrome (LGS), and Dravet syndrome in patients aged 2 years and older.
The first in a new category of antiepileptic drugs (AEDs), Epidiolex is a prescription formulation of highly-purified, plant-derived CBD, a cannabinoid lacking the high associated with marijuana. This is the first FDA approval of a drug to treat Dravet syndrome.