First marijuana-derived medicine approved by US will to be used to treat childhood epilepsy

The US Food and Drug Administration on Monday approved the first drug derived from marijuana, which will be used to treat two rare and severe forms of childhood epilepsy.

The drug, called Epidiolex, is an oral solution containing highly purified cannabidiol (CBD), which is one of scores of chemicals in the cannabis sativa plant, commonly known as marijuana. The drug contains only trace amounts of the psychoactive element THC and does not induce euphoria.

Epidiolex was approved for patients aged two and older who suffer from Lennox-Gastaut and Dravet syndromes. Both cause uncontrolled daily seizures and put patients at high risk for other physical and intellectual disabilities, injury and early death.

The disorders afflict fewer than 45,000 people in the United States, but experts expect Epidiolex to be prescribed for other types of epilepsy as well. The drug is the first treatment approved for Dravet syndrome.

FDA Commissioner Scott Gottlieb said the approval was “a reminder that advancing sound development programmes that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.”

The medication, tested in three randomised, placebo-controlled trials with more than 500 patients, was effective in reducing seizures, the FDA said.