The drug is called Epidiolex and is a plant-derived oral solution of cannabidiol (CBD)-a chemical component of marijuana that does not cause intoxication or a euphoric "high". Epidiolex contains less than 0.1% of THC. It does not contain THC, the well-known psychoactive component of marijuana responsible for the drug's characteristic high.
"I'm really happy we have a product that will be much cleaner and one that I know what it is", said Dr. Ellaine Wirrell, director of the Mayo Clinic's program for childhood epilepsy. "And, the FDA is committed to this kind of careful scientific research and drug development", said Gottlieb.
The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals.
The medicinal acknowledgment of CBD should come as good news to marijuana startups eyeing the compound for consumer and medical consumption.
The FDA notes that it will still "take action" against illegal CBD products making "serious, unproven medical claims".
"This is an important medical advance", Gottlieb said to STAT.
"We get at least one inquiry a day from patients either using, or considering using, CBD that they ordered online".
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Although several states have legalized the medical and recreational use of marijuana, the federal agency had yet to do so until today.
GW Pharmaceuticals, the British company responsible for the drug, said now approved AEDs (anti-epileptic drugs) are not always effective in the majority of patients with Lennox-Gastaut Syndrome (LGS) and Dravet syndrome - severe forms of childhood-onset epilepsy. This treatment we have studied for the last five years.
Both Dravet Syndrome and Lennox-Gastaut syndrome are diagnosed by a clinical exam and EEG by a doctor, ideally a doctor who specializes in brain conditions for children, known as a pediatric neurologist. The agency is expected to make this classification within 90 days. However, Schultz says his company plans to create more CBD medications.
The FDA still hasn't given its blanket approval to marijuana as a "safe and effective drug", though it has OK'd three medications that contain synthetic compounds similar to those found in the marijuana plant.
That means that - just as with any other drug - as long as pharmaceutical companies can demonstrate they've subjected a marijuana-derived candidate to large, well-designed clinical trials, it has a fair chance of being seriously considered for approval by the FDA. GW won't be able to market Epidiolex until the DEA reclassifies CBD.
"In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD", Devinsky said.
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. It's in phase 3 testing for a potential approval in the U.S. The company is also working on cannabinoid programs against glioblastoma, schizophrenia and more.