On June 25, the US Food and Drug Administration (FDA) approved the first drug based on compounds found in marijuana. This decision comes despite the fact that the US Drug Enforcement Agency lists the plant itself as a schedule 1 drug—meaning it has no recognized uses with a high potential for abuse.
Epidiolex, made by the British company GW Pharmaceuticals, is now marketed to treat two forms of severe childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. These illnesses can be fatal, and if a person survives through childhood, they often cause life-long disability. There are only a few pharmaceutical treatments for patients living with Lennox-Gastaut, no pharmaceutical options for those living with Dravet syndrome.
The newly-approved drug is a fruit-flavored liquid (it is for children, after all), that contains cannabidiol (CBD), one of hundreds of compounds found in the marijuana plant. The one you’ve likely heard the most about is tetrahydrocannabinol (THC), which is the component in the plant that causes highs. CBD doesn’t have those sorts of psychoactive effects, but has been found to alleviate pain, anxiety, and nausea, and to control seizures. It’s not clear how cannabinoid stops seizures, but some parents in US states where medical marijuana is legal already give CBD to their children with other forms of epilepsy, the AP reports. Epidiolex is a highly-concentrated, medical-grade version of the product.
The FDA’s decision comes after a year of promising steps forward. In 2017, GW Pharmaceuticals reported results from a clinical trial testing Epidiolex in children with Dravet, where it was found to cut the number of seizures in half for 40% of patients; three patients stopped having seizures altogether. In April of this year, advisors to the FDA voted unanimously to support the drug on its way to approval.
As the Washington Post reports (paywall), this approval will likely spur the DEA to give CBD a separate classification from marijuana within 90 days, as is required by a 2015 law. Currently, CBD is only legal in some states, depending on their laws with regard to marijuana use. The DEA may choose to reclassify all CBD, or only those products that also have FDA approval. Meanwhile, Epidiolex is not yet available in Britain and Europe; it’s still pending approval by the European Medicines Agency, which is expected to make a decision in early 2019.