The US Food and Drug Administration announced the approval of the country’s first marijuana-based prescription medication June 25. The drug is called Epidiolex. This drug is a plant-derived oral solution of cannabidiol, commonly known as CBD. CBD is a chemical component of marijuana and it does not cause intoxication; it does not get you high.
The FDA has just approved it for use with patients aged two and older who suffer from epilepsies known as Lennox-Gastaut syndrome and Dravet syndrome. This is the first time FDA has approved a drug derived from cannabis and it is the first time the FDA has approved a drug to treat Dravet syndrome.
The next hurdle is getting the US Drug Enforcement Administration to reclassify CBD, which like all cannabis, is currently classified as a Schedule I drug. Schedule I drugs include heroin and LSD and marijuana because they are said to have high abuse potential, no medical use, and severe safety concerns. Schedule I drug use, including medical use, is against federal law. GW Pharmaceuticals, the creator of Epidiolex, won’t be able to market the drug unless the DEA reclassifies CBD.
GW expects that the DEA will reschedule CBD within 90 days. In a statement, GW CEO Justin Gover said:
Today’s approval of EPIDIOLEX is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies. This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”
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