Epidiolex
Category: Medical · Level: Expert
Epidiolex is the first FDA-approved prescription pharmaceutical containing purified CBD, indicated for rare childhood epilepsy syndromes.
Epidiolex (cannabidiol oral solution, 100 mg/mL) is a prescription medicine developed by GW Pharmaceuticals (now Jazz Pharmaceuticals) and approved by the FDA in June 2018. It is the first plant-derived, purified cannabinoid to receive FDA approval and is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex in patients aged 1 year and older. Epidiolex contains pharmaceutical-grade CBD and is administered orally. Its approval represents a landmark in cannabis medicine legitimization and has influenced global medical cannabis regulation by establishing a regulatory pathway for cannabinoid pharmaceuticals.
Also known as
Pharmaceutical CBD, CBD drug, GW CBD
Usage
- Medical
- Legal
Regulatory notes
FDA approved June 2018. Rescheduled to Schedule V upon approval (from Schedule I). EMA approved Epidyolex in Europe in 2019.
Related terms
- CBD — Cannabidiol (CBD) is a non-psychoactive cannabinoid found in cannabis and hemp, widely used in medical research and consumer wellness products.
- Pharmaceutical Cannabis — Pharmaceutical cannabis refers to cannabis-derived medicines that meet pharmaceutical manufacturing standards and are prescribed through formal medical channels.
- Medical Cannabis — Medical cannabis refers to cannabis or cannabis-derived products prescribed or recommended by a licensed healthcare professional for therapeutic purposes.
- Schedule I — Schedule I is the most restrictive classification under the US Controlled Substances Act, applied to substances deemed to have high abuse potential and no accepted medical use, including cannabis.