Claims for Patent: 11,400,055

Summary for Patent: 11,400,055

Title:	Use of cannabidiol in the treatment of epilepsy
Abstract:	The present disclosure relates to the use of cannabidiol (CBD) for the treatment of Tuberous Sclerosis Complex (TSC). In particular the TSC is treatment resistant and is characterised by generalised seizures or focal seizures with impairment. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Inventor(s):	Guy; Geoffrey (Cambridge, GB), Wright; Stephen (Cambridge, GB), Thiele; Elizabeth (Boston, MA)
Assignee:	GW Research Limited (Cambridge, GB)
Application Number:	17/340,885
Patent Claims:	1. A method of treating seizures in a patient suffering from Tuberous Sclerosis Complex (TSC) comprising administering a drug product comprising a cannabidiol (CBD) drug substance to the patient, wherein the CBD drug substance has a purity of at least 95% (w/w) CBD and comprises no more than 0.15% (w/w) .DELTA.9-tetrahydrocannabinol, and wherein the CBD is administered at a starting dose of 5 mg/kg/day, and then the starting dose is increased by 2 to 5 mg/kg increments, up to 25 mg/kg/day. 2. The method of claim 1, wherein the TSC is treatment resistant. 3. The method of claim 1, wherein the administering treats generalized seizures or focal seizures with impairment. 4. The method of claim 3, wherein the generalized seizures include one or more seizure sub-types selected from the group consisting of tonic; atonic; tonic-clonic; and absence seizures. 5. The method of claim 3, wherein the CBD is increased to a dose of 25 mg/kg/day. 6. The method of claim 4, wherein the CBD is increased to a dose of 25 mg/kg/day. 7. The method of claim 3, wherein administering reduces the number of generalized seizures or focal seizures with impairment. 8. The method of claim 7, wherein the number of generalized seizures or focal seizures with impairment is reduced by at least 50% compared to the number of generalized seizures or focal seizures with impairment experienced during a baseline period before CBD was administered. 9. The method according to claim 1, wherein CBD is present as a synthetic compound. 10. The method according to claim 1, wherein the CBD drug substance is a highly purified extract. 11. The method according to claim 1, wherein the CBD drug substance has a purity of at least 98%. 12. The method according to claim 1, wherein the dose of CBD is increased to 20 mg/kg/day. 13. The method according to claim 1, wherein the dose of CBD is increased to 25 mg/kg/day. 14. The method according to of claim 1, wherein the dose of CBD is increased to 10 mg/kg/day. 15. The method according to of claim 1, wherein the dose of CBD is increased to 15 mg/kg/day. 16. The method of claim 1, wherein the drug product comprises sesame oil, and a sweetener, flavoring agent, or combination thereof. 17. The method of claim 1, wherein the starting dose is increased by 5 mg/kg increments.