DEA Reclassified CBD-Based Drug, Epidiolex, to Show Lowest Risk for Abuse
The Drug Enforcement Administration has reclassified some CBD products from Schedule I to Schedule V. CBD, or cannabidiol, is a derivative of marijuana that does not cause psychoactive effects. The change in classification is the result of the Food and Drug Administration approving a CBD-based epilepsy drug in June.
Though the DEA has reclassified the FDA-approved drug, Epidiolex, it did not reclassify CBD totally. “Marijuana and CBD derived from marijuana remain against the law, except for the limited circumstances that it has been determined there is a medically approved benefit,” the agency said.
As of now, Epidiolex is the only CBD-product in Schedule V, but other CBD-based medications could be placed in Schedule V in the future. Its approval paves the way for more research and potentially other FDA-approved medications with CBD. According to Business Insider, this is the first time in 46 years that the DEA has changed its stance on a marijuana compound.
Schedule V is the lowest classification, meaning the drug has the lowest risk of abuse and accepted medical uses. In contrast, Schedule I, which is where marijuana and other CBD products remain, consists of drugs the DEA believes has highest potential for abuse and no accepted medical use.
Epidiolex was approved to treat two forms of epilepsy — Dravet syndrome and Lennox-Gastaut syndrome. Dravet syndrome is a rare form of epilepsy that typically begins before the age of 1. Lennox-Gastaut affects up to 2 to 5 percent of all childhood epilepsy cases. Lennox-Gastaut is a chronic condition that causes intellectual disabilities. Both of these disorders have high mortality rates, according to GW Pharmaceuticals, the company behind Epidiolex.
The drug is approved to treat patients 2 years and older. GW Pharmaceuticals expects to have the medication, which is an oral solution, available in the next six weeks. The medication, though, will not come cheap. Business Insider recently reported the drug would cost approximately $32,500 a year. Julian Gangolli, the head of commercialization for GW in the U.S., told Business Insider the price is on par with other epilepsy medications and that co-pays could be less than what people spend on CBD products online or in dispensaries.
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