FDA approves its first cannabis based medicineBMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k2827 (Published 27 June 2018) Cite this as: BMJ 2018;361:k2827
- Jacqui Wise
The US Food and Drug Administration has approved the first prescription drug derived from marijuana for treating two rare and severe forms of epilepsy.
Epidiolex has been approved for treating seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 2 years or older.1 These forms of epilepsy are frequently resistant to currently available treatments.
The oral solution, developed by the UK based company GW Pharmaceuticals, contains purified cannabidiol (CBD), a chemical component of the Cannabis sativa plant. However, CBD does not cause the intoxication or euphoria that comes from tetrahydrocannabinol (THC). Before the drug can be marketed the Drug Enforcement Administration must reclassify cannabidiol: it is currently considered a schedule drug, meaning that it has no medical value and a high risk of misuse. It is expected …