FDA Panel Advises FDA to Approve Epidiolex, a CBD-Based Drug For Epilepsy
Update: The FDA approved Epidiolex on June 25. The Drug Enforcement Agency will have to reclassify CBD because marijuana and its derivatives are considered Schedule I drugs — a classification given to illicit substances with no medicinal value. The DEA is expected to reclassify within 90 days.
On Thursday, an advisory committee for the Food and Drug Administration recommended the FDA approve a prescription CBD (cannabidiol) medication for the treatment of some rare epilepsy disorders.
The drug, Epidiolex, was unanimously backed by the committee. The FDA is slated to make a final decision on the medication’s approval June 27. The administration typically follows the decisions of its advisory committees.
Epidiolex, which is manufactured by GW Pharmaceuticals, was originally granted a fast track designation from the FDA in 2014. The designation facilitates drug development and speeds up the review process. Fast track designations are typically given for medications needed to treat serious conditions that have “an unmet medical need.”
The medication was fast-tracked to treat Dravet syndrome — a rare form of epilepsy that generally starts before the age of 1. Dravet syndrome is life-long and typically leads to a developmental disability. If approved, Epidiolex would be the first FDA-approved medication for Dravet syndrome. The drug also targets Lennox-Gastaut syndrome, which makes up 2 to 5 percent of all childhood epilepsy cases. Lennox-Gastaut is a chronic condition that causes intellectual disabilities. Both of these disorders have high mortality rates, according to the pharmaceutical company behind Epidiolex.
Epidiolex is CBD-based, meaning it is derived from the marijuana plant, but does not induce a “high” or an altered state. THC is the compound in cannabis that has psychoactive properties.
CBD has been used by patients for years to treat epilepsy and other conditions, though epilepsy currently has the strongest case for its efficacy. CBD is commonly sold as a “supplement” since it isn’t approved by the FDA, and supplements aren’t regulated by the agency. A popular brand of CBD is Charlotte’s Web, which was created in 2012 and named after a girl named Charlotte who has Dravet syndrome, who used the product to drastically reduce her seizures.
Though the medication would only be approved for the two forms of epilepsy, it is a step toward federal approval and recognition of CBD as a legitimate therapy for some disorders and illnesses.
Photo via Getty Images/OlegMalyshev