The Food and Drug Administration on June 25 approved for the first time a drug made from cannabidiol (CBD), a molecule derived from the cannabis plant. The drug, Epidiolex, was approved for the treatment of two types of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome, that have been resistant to treatment.
Well-designed clinical trials have shown that the Epidiolex product of CBD can be helpful in reducing or eliminating seizures in these epilepsy syndromes.
While medical marijuana supporters may cite the FDA approval of Epidiolex as evidence of the benefits of marijuana, it is not an endorsement of any CBD or cannabis product. This product differs from most other CBD products available in cannabis dispensaries in that it is a highly concentrated and purified pharmaceutical grade medicine. It is the only CBD product to receive FDA approval, at this time. Other pharmaceutical grade products may be developed and approved in the future. Additionally, this product could be approved by the FDA for other types of epilepsy or diseases.
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The next step in the process of making this CBD product available is rescheduling by the Drug Enforcement Agency. Currently, CBD is a Schedule I drug, meaning that it has abuse potential and no proven medical use. As a Schedule I drug, CBD use is greatly restricted and controlled. Now that the FDA has approved a medical use, the DEA has 90 days to reschedule the drug, making it available for medical uses.
It is unclear at this time what the DEA will determine as an appropriate schedule for CBD. Once the DEA has rescheduled CBD, the Epidiolex product will be available for physicians to prescribe. While the current FDA approval of this CBD product is for two specific epilepsy syndromes, the FDA does not restrict its use only to epilepsy. Physicians will be able to legally prescribe this product for any use when they believe there is sufficient scientific evidence.
As a professor of pharmacy with a special interest in epilepsy, I find it important that CBD may be a new option for the treatment of epilepsy. This new use has led me to carefully study published literature on CBD and discuss it as an option with patients who have epilepsy. Additionally, I have been involved with the American Epilepsy Society’s ongoing review of CBD as a possible treatment for epilepsy. From this perspective, I believe that CBD may offer benefits for patients with some types of epilepsy and possibly other disorders.