GB2593590A — Methods of treating tuberous sclerosis complex with cannabibiol and everolimus

USPTO Abstract

Cannabidiol (CBD) for use in the treatment of seizures associated with tuberous sclerosis complex (TSC) is provided, characterised in that the CBD is administered at a reduced dose and is administered in combination with everolimus. Preferably the reduced dose of CBD is at least about 10% less than the dose of CBD that would otherwise be administered in the absence of everolimus. Preferably the dose of everolimus is from 2mg to 10mg and preferably the reduced dose of CBD ranges from 5mg/kg/day to 20mg/kg/day. The CBD may be present as synthetic CBD or may be present as a highly purified botanical drug substance having a purity of at least 95% w/w. Cannabidiol (CBD) for use in the treatment of seizures associated with TSC, characterised in that the CBD is administered to a everolimus-naïve patient, which is currently treated with CBD, comprising (a) co-administering everolimus to the everolimus-naïve patient; (b) monitoring the patient’s blood plasma concentrations of everolimus; and (c) if the patient’s blood plasma trough concentrations of everolimus exceed 15ng/mL, or if the patient’s Cmax exceeds 50ng/mL or AUC0-24 500h*ng/mL, then reducing the dose of everolimus by at least 10%, is also provided.