Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD), has been reclassified today by the US Drug Enforcement Administration to Schedule V — the lowest restriction classification available under federal law. The US Food and Drug Administration had previously approved the product in June for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. It is the first botanically-derived medicine from cannabis to receive US market approval.
A spokesperson for the DEA affirmed that the change is only specific to Epidiolex, and does not amend the schedule I status of either whole-plant cannabis or CBD — stating: “As of right now, any other CBD product other than Epidiolex remains a Schedule I Controlled Substance, so it’s still illegal under federal law.”
The drug’s manufacturer estimates that physicians will likely be able to begin prescribing the medicine within six weeks. An annual prescription is anticipated to cost patients $ 32,500.
Commenting on the scheduling change, NORML’s Deputy Director Paul Armentano said: “The DEA’s rescheduling of this plant-derived medicine provides an additional option to patients seeking the therapeutic benefits of cannabis. However, it remains to be seen to what degree physicians will be comfortable prescribing this new agent, and whether most patients can feasibly afford it.”
He added: “We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant. These are welcome alternatives. But these products should not be regulated in such a manner that patients no longer have ready access to herbal cannabis — a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 31 states.”
Epidiolex was developed in the United Kingdom. US regulations do not permit private companies to engage in marijuana-derived medicine development, since only the University of Mississippi is federally licensed to cultivate cannabis strains for clinical research purposes.
Schedule V substances, as defined by the US Controlled Substances Act, are medicines deemed to possess a “low potential for abuse,” and may be associated with “limited physical dependence or psychological dependence.”
