For the first time, the US Food and Drug Administration (FDA) has approved a drug made from cannabis.
Epidiolex treats severe forms of childhood epilepsy with CBD. Now that the FDA has validated it, the DEA (Drug Enforcement Administration) will need to requalify this form of cannabis before the drug is available on the market.
Epidiolex: A reclassification needed by the DEA
Indeed, for almost half a century, the DEA has classified cannabis in the list of Schedule I drugs. It is considered in the same way as heroin and LSD. In comparison, cocaine and methamphetamine are Schedule II drugs. Annex I drugs "are not considered to have a currently accepted medical use and have a high potential for abuse."
As a result, it is extremely difficult for scientists to research the substance and pharmaceutical companies are not allowed to use it.
But now, the FDA has approved Epidiolex as a medicine. Epidiolex contains cannabidiol, or CBD, which is administered as an oil.
According to DEA spokesman Melvin Patterson, the administration had considered reclassifying the CBD and "the FDA's findings on Epidiolex will weigh heavily on the decision-making process."
However, there is no update as to whether the approval will change the schedule for the proposed reclassification. The DEA could simply reclassify the CBD, but leave the cannabis itself in Appendix I.
To better understand this issue, it is a federal decision, which applies across the territory. The process of legalization that we observe in the US is not federal, but depends on each state. Every decision taken at the federal level is therefore fundamental.
Epidiolex treats two forms of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome, which rarely respond to conventional treatment.
GW Pharmaceuticals manufactures this medicine. Clinical trials have shown that children taking Epidiolex had about 40% fewer seizures per month.
A return of research on cannabis
However, this decision concerns "a single compound that comes from the plant and has received approval for two very specific forms of epilepsy," Friedman said. This associate professor of neurology at the Comprehensive Epilepsy Center of NYU Langone is co-author of a study on Epidiolex to treat Dravet syndrome.
But doctors may prescribe inappropriate use for other forms of epilepsy. Thus the FDA approval could have a domino effect that leads to the reclassification of the DEA. The first consequence: a revival of cannabis research in the USA.