Epidiolex First CBD Medication Approved by FDA in the U.S.

In early November U.K. based GW Pharmaceuticals received approval by the United States Food and Drug Administration (FDA) for doctors to prescribe the cannabis-derived CBD medication Epidiolex in all 50 states. This is historic in that Epidiolex is the first cannabis-based drug to be approved by the FDA. This medication is used for patients two years and older to offset epileptic seizures for Dravet Syndrome and Lennox-Gastaut Syndrome, two rare seizure disorders that affect children in their early years of development. As stated by FDA Commissioner Dr. Scott Gottlieb, “The FDA will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and stand ready to work with product developers who are interested in bringing patients safe and effective, high quality products.” 

Listed by GW Pharmaceuticals at an average yearly price of $32,500 Epidiolex is aligned with other FDA-approved anti-epileptic drugs in terms of price point and will be launched with a patient support program to aid access to therapy through insurance plans which “help lower out-of-pocket costs or provide product at no cost for eligible patients.”

Now that Epidiolex has been approved by the FDA, doctors can lawfully prescribe the drug for “off-label” use in other conditions. This will surely play a pivotal role in paving the way for other CBD based medications, reducing their barriers to entry for FDA approval and opening the market for treatments of a myriad of other disorders that can benefit from the use of CBD oils.