Epidiolex

Epidiolex is a highly purified, plant-derived cannabidiol (CBD) oral solution at 100 mg/mL with no more than trace THC. The FDA approved Epidiolex on June 25, 2018 for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients ≥2 years of age, following a unanimous 13–0 advisory committee vote. A supplemental indication for tuberous sclerosis complex (TSC) was added in 2020. Epidiolex was initially placed in Schedule V by the DEA (September 2018) but was fully descheduled and removed from the Controlled Substances Act effective April 6, 2020, with final rulemaking published August 21, 2020. The product was developed by GW Pharmaceuticals and its U.S. subsidiary Greenwich Biosciences; GW was acquired by Jazz Pharmaceuticals for $7.2 billion in a cash-and-stock deal that closed in May 2021. The product is marketed in the European Union and United Kingdom under the name Epidyolex, first authorized by the EMA in 2019. → See also: Cannabidiol, Jazz Pharmaceuticals.