DEA classifies Epidiolex as off schedule 1

In June, the Food and Drug Administration approved the drug Epidiolex, a CBD oil intended to treat certain cases of epilepsy. Following this approval, the DEA then had 90 days to reclassify the substance off the schedule 1 of the Controlled Substances List (CSA) Now that Epiodiolex has been approved by the FDA, it now has a recognized therapeutic use in the United States (...) accordingly, [it] no longer corresponds to the classification criteria of the Schedule 1 of the CSA,» explained Uttam Dhillon, DEA administrator, in a press release.

Schedules

Visit schedules are defined by three criteria: abuse potential, recognized medical benefit in the USA, and the safety and dependence potential of the substance. The schedule 1 includes substances considered dangerous and of no medical interest. From schedule 2, there is a potential for abuse but a recognized medical benefit. The schedules then decrease with the degree of abuse potential and dependence.

Epidiolex is the first authorized medicine derived directly from cannabis and has been listed on the schedule 5 which is the least restrictive. The schedule 5 lists preparations which contain a certain dose of narcotics, but which themselves have medical value and low abuse potential. Although Epidiolex is essentially composed of CBD, the latter remains classified under the schedule 1 as the whole cannabis plant: «any compound, material, mixture and preparation other than Epidiolex that falls under the CSA definition of cannabis (...) including non-FDA approved CBD extractions remains a Class 1 controlled substance».»

It seems inconsistent that cannabis, and even more so CBD, is always placed in the schedule 1 since, by recognizing the medical value of Epidiolex, reclassification also implies recognition of the medical value of cannabis, and at least of the CBD molecule, whose harmlessness and lack of abuse or dependence potential have been recognized by the UN. As for the whole plant, a classification under the schedule 2 could recognize both its dangerousness and its medical value, like morphine, for example.

Gradual recognition

On this point, it seems that the federal administration is proceeding cautiously, drug by drug. The FDA had previously approved drugs containing synthetic cannabinoids (THC and dronabinol), namely Marinol and Syndros. The DEA has classified these drugs as schedule III and II. It seems that reclassifications will be based on clinical trials and FDA approvals, but that reclassification of the whole plant is not on the agenda. It will thus remain federally prohibited for some time, despite the fact that it is now legal in many states. «The DEA will continue to support relevant scientific research that promotes legitimate therapeutic uses for FDA-approved cannabis components consistent with federal law,» said Dhillon.

The CEO of GW Pharmaceuticals, With the completion of this final step in the regulatory process, we are working hard to make Epidiolex available in the next six weeks, as we know there is enthusiasm for a standardized version of cannabidiol that has passed the rigors of controlled clinical trials and been approved by the FDA. Thanks to this status GW Pharmaceuticals will be the only one to be authorized nationwide, and will surely be a reference choice for doctors. Although schedule 5, the drug is still on the Controlled Substances List and will therefore be subject to strict regulations. In particular, it will only be available with a doctor's prescription.