FDA approves first cannabis-based drug

US health regulators approve seizure drug made from marijuana

On Monday the agency approved its first marijuana-derived drug, Epidiolex, for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two rare forms of pediatric epilepsy.

The drug, GW Pharmaceuticals' Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high. Though other drugs are approved to treat Lennox-Gastaut syndrome, Epidiolex is the first licensed to treat Dravet syndrome.

While there was initially some confusion about whether the Drug Enforcement Administration might block the sale of Epidiolex, given cannabis' status as a Schedule I substance, Epidiolex manufacturer GW Pharmaceuticals doesn't believe that will be the case.

Today's approval "serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies".

"This is clearly a breakthrough drug for an bad disease", John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug.

"For those living with intractable seizures caused by LGS and Dravet syndrome, Epidiolex represents a true medical advancement", said Philip Gattone, president and CEO of the Epilepsy Foundation.

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According to Dr. Angel Hernandez, of the Helen DeVos Children's Hospital in Grand Rapids, Mich., these results prove that pharmaceutical-grade CBD helps suppress seizures and "increases our options to treat many of these patients with very, very difficult-to-control epilepsies". The drugs are listed as Schedule II and Schedule III, meaning they have medicinal value but also potential for abuse.

Ohio's medical marijuana law allows people with one of 21 medical conditions to buy and use medical marijuana if recommended to them by a physician. GW won't be able to market Epidiolex until the DEA reclassifies CBD. However, it isn't clear whether such a reclassification would involve CBD products in general, the CBD formulation used specifically in Epidiolex or something else.

Ohio's medical marijuana program was expected to be operational in early September but now has no definite start date, and none of the approved cultivation centers has begun growing the plant. Experts are hopeful that the approval will unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.

The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals. The chemical's use in seizure prevention is well-documented in reputable research, and now, after conducting its own trials, the FDA is on board.

"For a maligned substance like cannabis, I think the vindication tour will ultimately be years long", said Ricardo Baca, a former marijuana editor at the Denver Post, and the founder of Grasslands, a cannabis PR agency.

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