Human medicines European public assessment report (EPAR): Epidyolex, cannabidiol, Lennox Gastaut Syndrome;Epilepsies, Myoclonic, Date of authorisation: 19/09/2019, Revision: 13, Status: Authorised
Five studies in over 900 patients with Lennox-Gastaut syndrome, Dravet syndrome or TSC showed that Epidyolex lowered the number of seizures when added to treatment with other epilepsy medicines after 14 to 16 weeks of treatment.
In the first two studies, patients with Lennox-Gastaut syndrome taking Epidyolex in combination with clobazam had a reduction of up to 64% in the number of drop seizures (brief loss of muscle tone and reduced consciousness, causing abrupt falls), compared with a reduction of up to 31% for patients given placebo (a dummy treatment) with clobazam.
In another two studies in patients with Dravet syndrome, the reduction in the number of convulsive seizures (major fits with loss of consciousness) was up to 61% for patients taking Epidyolex and clobazam, and up to 38% for patients on placebo and clobazam.
In a fifth study, patients with TSC taking Epidyolex at maximum dose of 25/mg/kg/day had a reduction of 49% in the number of seizures compared with 27% in patients receiving a placebo.
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