The US Food and Drug Administration approved the first cannabis drug this week, but it can only be sold if the Drug Enforcement Administration changes the classification of the substance used. What's next?
Epidiolex treats severe forms of childhood epilepsy and contains the compound cannabidiol (CBD). Although CBD comes from cannabis, it will not make anyone get high; it is the compound THC that is psychoactive. However, as cannabis and cannabis are generally classified as a "Schedule I" drug with "no currently accepted medical use and high abuse potential," pharmaceutical companies may only sell it when the DEA reclassifies CBD.
It's likely that the DEA will reclassify the CBD over the next 90 days, says Stephanie Yin, an analyst at Informa Pharma Intelligence. (Epidiolex manufacturer GW Pharmaceuticals has said the same thing.) Most likely, according to Yin, it will be changed to Schedule IV or Schedule V, which plans include other anti-seizure drugs and anxiety drugs like Xanax and Klonopin.
This does not mean that cannabis is being removed from List I as a drug. Yin points out that the FDA has already approved two nausea drugs ̵
If these synthetic THC drugs can be approved and postponed and CBD postponed, what's left for the DEA to switch cannabis itself? "Cannabis contains so many different compounds and strains," explains Yin. "The FDA has just approved this unique product through rigorous testing and dosages and specific concentrations, it has been subjected to rigorous clinical trials and FDA review, but the FDA will still stubbornly resist claims by other products."
To be sure To say that there are already many CBD products, from supplements to oils to various beauty products like soap. But it's one thing to sell as supplements and another to sell them as drugs. "You can get vitamin C from oranges at the grocery store, or you can get a clinical preparation of vitamin C to treat a disease, and these two products are treated very differently," says Chris Stubbs, chief science officer for hemp cultivation and genetics company GenCanna. Clinical CBD is much stricter regulated.
Nonetheless, reclassification is likely to make medical cannabis more legitimate. Rite Aid, for example, has already announced that it will meet the prescriptions for Epidiolex, which is expected to be available in pharmacies in the fall. (It will not be available in pharmacies, as FDA-approved drugs can only be sold in locations with a pharmaceutical license.) And GW Pharmaceuticals is already investigating other CBD-derived drugs for the treatment of various forms of epilepsy and brain cancers and schizophrenia. "This approval will certainly encourage other companies to investigate [other cannabis] compounds for various diseases," she says, "from Pain to Alzheimer's, from Multiple Sclerosis to Tourettes." Basically a whole spectrum of diseases. "