FDA Expands Prescription Use of Cannabis Plant-Derived Therapy

Washington, DC: Regulators with the US Food and Drug Administration (FDA) granted approval on Friday for the use of the cannabis plant-derived prescription drug Epidiolex in patients with the genetic disorder tuberous sclerosis complex (TSC).

The disorder is characterized by the growth of benign tumors in various parts of the body. The condition may also cause neurological changes which may result in personality changes and involuntary seizures. Epidiolex, which primarily consists of plant-derived CBD, was previously approved as an anticonvulsant by the FDA in 2018 for patients with two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

The drug had previously been shown to reduce seizure frequency and be well-tolerate in TSC patients in a series of clinical trials, suggesting that the mechanism of action of CBD’s anti-seizure activity is not limited solely to those with epilepsy.

For more information, see NORML’s Fact Sheet, “FAQs About Cannabidiol.”