Administrator Gottlieb warns against 'the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims'
Potheads unite! FDA has approved the first drug derived from marijuana, Epidiolex, from GW Pharmaceuticals PLC, which has been working toward this approval for years. Epidiolex is the branded version of cannabinoid (CBD) which, the FDA announcement was careful to highlight, is not tetrahydrocannabinol (TC)—the component of marijuana that gives users a high. Nevertheless, one can expect proponents of marijuana use, whether for medical or recreational purposes, to crow about the plant's health value.
Epidiolex is approved for two rare, severe types of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, which cause seizures in children. Randomized, double-blind, placebo-controlled trials involving 516 patients were the basis for the approval. It will be dispensed with a Medication Guide—specific instructions for prescribing and for use—but, interestingly, the drug remains for the time being a Schedule I controlled substance under the Drug Enforcement Administration, which makes it illegal to possess or dispense. (FDA says that DEA is required by law to make a scheduling determination, presumably to re-list the substance as Schedule II, which is legal to dispense by a pharmacist.)
FDA Commissioner astutely recognized that this approval will generate intense interest in medical marijuana, and issued an accompanying statement, which reads in part: “This is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.”
Epidiolex is the first approved treatment for Dravet syndrome. The drug received Priority Review under FDA, and was also granted orphan drug status. GW Pharma says that Epidiolex is under review in the European Medicines Agency, and approval could be expected in 2019.