Efficacy

Epidyolex has been assessed in a large clinical development program within Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS), including 714 patients. At the request of the regulatory agency a post-hoc subgroup analysis has also been carried out for the patients receiving Epidyolex and clobazam concomitantly.1

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efficacy

The recommended starting dose is 2.5 mg/kg twice daily. Based on individual clinical response and tolerability, if required this can increase in weekly increments of 2.5 mg/kg twice daily up to the maximum recommended dose of 20 mg/kg/day.1  Any dose increases above 10 mg/kg/day, up to the maximum recommended dose of 20 mg/kg/day, should be made considering individual benefit and risk and with adherence to the full monitoring schedule.1

Select condition:
Lennox-Gastaut syndrome
Dravet syndrome
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References

 

1. Epidyolex SmPC (Date accessed: 03/09/2020).

 

2. GW Pharmaceuticals. Data on File: VV-MED-06680 (v1). 2019.

 

3. GW Pharmaceuticals. Data on File: VV-MED-06681 (v1). 2019.