USA: Epidiolex is no longer a controlled substance

GW Pharmaceuticals announced on Monday that Epidiolex, a cannabidiol (CBD) used in the treatment of epilepsy, had been removed from Schedule V of the U.S. Controlled Substances Act. Drug Enforcement Administration (DEA).

People who could benefit from it will now be able to obtain it more easily. GW said in its press release that it «will now begin the process of implementing these changes at state level and via the EPIDIOLEX distribution network».

As with many non-controlled drugs, patients or their legal representatives will still need to obtain a prescription from a doctor, but these prescriptions will be valid for up to a year, and can be transferred between pharmacies.

«This DEA notification fully establishes that EPIDIOLEX, the only FDA-approved CBD medication, is no longer a controlled substance under the federal Controlled Substances Act,» said Justin Gover, CEO of GW Pharmaceuticals, in a press release. «We would like to thank the DEA for confirming the uncontrolled status of this drug.»

«Importantly, the declassification of EPIDIOLEX will facilitate patient access to this important therapy for patients living with Lennox-Gastaut syndrome and Dravet syndrome, two of the most disabling forms of epilepsy,» he said.

The Food and Drug Administration (FDA) approved the use of Epidiolex in 2018. DEA classified it in Appendix V from the list of controlled substances, unlike cannabis and its derivatives listed in Annex I, the most restrictive.

The FDA strongly encouraged the DEA to remove Epidiolex from controlled substances, arguing that CBD poses minimal risks, has established health benefits and should not be controlled at all. The DEA replied that international treaty obligations justified its control, albeit in the least restrictive category, Schedule V. The FDA felt that if CBD's international status changed, the DEA should «promptly» review its status as a controlled substance.

Last year, the World Health Organization (WHO) specified that preparations containing CBD, with no more than 0.2% THC, should not be «under international control».

In the meantime, the FDA has reworked its regulations for hemp-based products in response to its legalization at the federal level as part of the Farm Bill 2018. CBD should soon be considered a dietary supplement, which would open up a regulatory pathway for all CBD products already on the US market.