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NICE recommends new therapy for a rare epileptic condition

National Institute for Health and Care Excellence has recommended cannabidiol (Epidyolex) with clobazam as a treatment option for seizures associated with Dravet syndrome.

Cannabidiol with clobazam is recommended for the treatment of individuals aged ≥two years having seizures associated with Dravet syndrome, if the frequency of convulsive seizures is assessed every six months and cannabidiol is discontinued in the absence of a minimum 30 per cent decline in frequency compared with the six months prior to starting treatment.

The recommended starting dosage for cannabidiol is 2.5 mg/kg twice daily for one week, followed by dose escalation to a maintenance dosage of 5 mg/kg twice daily. Subject to individual benefit and risk, the dosage may be further increased in weekly increments of 2.5 mg/kg twice daily up to a maximum dose of 20 mg/kg/day.

Evidence from clinical trials has shown a reduction in the number of convulsive and non-convulsive seizures with cannabidiol vs usual care. The drug is to be used only when provided by the company in agreement with the commercial arrangement. The recommendations should not affect patients whose treatment with the drug was started before the publication of the guidance.


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