The Food and Drug Administration on Monday [June 25] approved the country’s first drug derived from marijuana, a medication that treats two rare and devastating forms of epilepsy.
The drug, GW Pharmaceuticals’ Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high. It is given as an oil, and in clinical trials, it was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb said in a statement.
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Before GW can market Epidiolex, though, the Drug Enforcement Administration will have to reclassify CBD, which in this case, because it comes from marijuana, is considered a Schedule I drug, meaning it has no medical value and a high risk of abuse. The agency is expected to do so within 90 days.
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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…
Although Epidiolex was only approved for the two specific conditions, analysts expect doctors to prescribe it off label for a variety of epileptic diseases.
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