November 13, 2018

FDA approves its first marijuana-derived drug

26 June 2018, 03:26 | Rodolfo Wallace

He added that the drug offers families "the first and only FDA-approved cannabidiol medicine to treat two severe, childhood-onset epilepsies".

The FDA says this is the first drug approved in the USA that contains a purified substance derived from marijuana.

Patients with Lennox-Gastaut and Dravet syndromes, which typically emerge in the first few years of life, can suffer from debilitating and recurrent seizures, sometimes dozens a day.

With the historic approval, the London-based company behind the drug, GW Pharmaceuticals plc, is expecting another consequential decision in the coming weeks: getting the US Drug Enforcement Administration to reclassify CBD. That so-called "high" comes from a different compound in marijuana, known as tetrahydrocannabinol (THC).

Once the DEA gets the FDA recommendation for how CBD should be scheduled, it has 90 days to decide.

A phase three clinical trial is underway for a third seizure-related condition called tuberous sclerosis complex, which begins in infancy and causes a sudden stiffening of the body, arms and legs, with the head bent forward.

The European Medicines Agency is now reviewing Epidiolex for treating seizures associated with LGS and Dravet Syndrome, with a decision on whether or not to recommend approval expected early next year. The agency may ignore the FDA's position, but that is considered unlikely in this case. The new drug is anticipated to become available to patients later this fall.

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A drug made from a derivative of marijuana has been approved for patients with certain forms of epilepsy.

Fox hailed Monday's FDA action as a win for the broader medical marijuana community, in that it will facilitate more clinical research into the drug's medical benefits.

In a statement accompanying Monday's approval announcement, the FDA hastened to note that it's not signing off on the safety or medical utility of marijuana in general ― just this one compound and only for this limited use. But it's not quite medical marijuana.

Called Epidiolex, the drug is created to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD). And Epidiolex could well be the first in a wave of marijuana-based therapies; agency officials said they have implemented regulatory processes to help drug developers test marijuana or its components in their own clinical trials. Despite the medication's approval, cannabis remains a Schedule I substance, which, according to the federal government, means it has "no accepted medical uses".

"The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", Gottlieb said.

Across the board, the drug was shown to be effective in cutting the frequency of seizures.

"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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