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News From the Food and Drug Administration
September 15, 2020

CBD Drug Is Approved for a Third Form of Epilepsy

JAMA. 2020;324(11):1026. doi:10.1001/jama.2020.16782

A drug containing the marijuana derivative cannabidiol (CBD) was approved to treat seizures associated with tuberous sclerosis complex (TSC) in patients aged 1 year or older. TSC is a genetic disease that causes benign tumors to grow throughout the body. It affects 1 in 6000 people.

The drug, marketed as Epidiolex, is the only FDA-approved drug with CBD as an active ingredient. It was approved in 2018 to treat seizures in patients with Dravet or Lennox-Gastaut syndromes.

FDA officials said Epidiolex’s effectiveness was established in a clinical trial involving 224 patients who had frequent TSC-associated seizures and took at least 1 antiepileptic drug. Results were presented at an American Epilepsy Society meeting in 2019. Patients were randomized to receive a daily liquid solution containing either 25 mg/kg or 50 mg/kg of CBD or placebo for 16 weeks. TSC-associated seizures decreased by 49% for patients who received the lower dose, 48% for patients who received the higher dose, and 27% for patients who took placebo.

Patients should be monitored for mood changes or suicidal thoughts and behaviors, FDA officials noted. They added that Epidiolex caused liver damage in some patients. The FDA previously required GW Pharmaceuticals, which markets Epidiolex, to assess the drug’s effects on the liver.

A company spokesman said pricing would adhere to “the weight-based dosing from previous pricing decisions.” In 2018, GW said list prices for the 2 initially approved indications would average $32 500 per patient annually.

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