Pharmaceutical-grade cannabidiol (Epidiolex) as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome received positive words from FDA staff in briefing documents issued in advance of an FDA advisory committee meeting that will be held Thursday.
The risk-benefit profile established by three clinical trials in LGS and Dravet syndrome “appears to support approval,” they wrote. The trials demonstrated clinically meaningful and statistically significant reductions in seizure frequency and their results “provide substantial evidence” of cannabidiol’s effectiveness in treating LGS and Dravet syndrome seizures, according to the review.
In light of this, possible risks associated with cannabidiol appeared acceptable: “Although the risk of liver injury has the potential to be serious, the observed risk can be appropriately managed with inclusion of relevant language in labeling, education of prescribers regarding the risk of transaminase elevation and need for monitoring of liver enzyme levels, and further characterization of
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