FDA Panel Votes to Recommend Cannabis-Based Epilepsy Drug

In a unanimous vote, the Peripheral and Central Nervous System Drugs Advisory Committee of the US Food and Drug Administration (FDA) has recommended the approval of Epidiolex, a cannabidiol product, for the treatment of seizures caused by Lennox-Gastaut and Dravet syndromes.

The committee recommended the approval following the success of various randomized clinical trials in which patients treated with Epidolex experienced about a 40% reduction in seizures per month.

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Reported side effects of Epidolex include hepatic adverse events and sleepiness.

The FDA is expected to announce its decision regarding approval by the end of June.

—Christina Vogt


FDA briefing document: Peripheral and central nervous system drugs advisory committee meeting. US Food and Drug Administration. April 19, 2018. Accessed on April 20, 2018.