Epidiolex
Category: Medical · Level: Expert
Epidiolex es el primer fármaco aprobado por la FDA que contiene CBD purificado, indicado para síndromes epilépticos infantiles raros.
Epidiolex (solución oral de cannabidiol, 100 mg/mL) es un medicamento recetado desarrollado por GW Pharmaceuticals (ahora Jazz Pharmaceuticals) y aprobado por la FDA en junio de 2018. Es el primer cannabinoide purificado derivado de plantas que recibe la aprobación de la FDA y está indicado para el tratamiento de convulsiones asociadas con el síndrome de Lennox-Gastaut, síndrome de Dravet y complejo de esclerosis tuberosa en pacientes de 1 año o más. Epidiolex contiene CBD de grado farmacéutico y se administra por vía oral. Su aprobación representa un hito en la legitimación de la medicina cannábica y ha influido en la regulación global del cannabis médico al establecer un camino regulatorio para los fármacos cannabinoides.
Also known as
CBD farmacéutico, medicamento de CBD, CBD de GW
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.