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 have 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 Schedule I list of drugs. It is considered the same as heroin and LSD. By comparison, cocaine and methamphetamine are Schedule II drugs. Schedule I drugs are considered to “have no 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 drug companies are not allowed to use it.
But now, the FDA has approved Epidiolex as medicine. Epidiolex contains cannabidiol, or CBD which is administered as an oil.
According to DEA spokesperson Melvin Patterson, the administration had considered reclassifying CBD and “the FDA's findings on Epidiolex will weigh heavily on the decision-making process. "
However, there is no update on whether the approval will change the timing of the proposed reclassification. The DEA could simply reclassify CBD, but leave cannabis itself in Schedule I.
In order to better understand this problem, this is a federal decision, which therefore applies throughout the territory. The legalization process that we observe in the USA 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 drug. Clinical trials have shown that children taking Epidiolex have almost 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," said Daniel Friedman. This associate professor of neurology at the Comprehensive Epilepsy Center at NYU Langone is co-author of a study on Epidiolex to treat Dravet syndrome.
But doctors could prescribe improper 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 renaissance of cannabis research in the USA.