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.
FDA briefing document: Peripheral and central nervous system drugs advisory committee meeting. US Food and Drug Administration. April 19, 2018. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM604736.pdf Accessed on April 20, 2018.