Use of cannabinoids in the treatment of epilepsy
The present disclosure relates to the use of cannabidiol (CBD) for the reduction of total convulsive seizure frequency in the treatment of “treatment-resistant epilepsy” (TRE). In particular, the disclosure relates to the use of CBD of treating TRE when the TRE is Dravet syndrome; myoclonic absence seizures or febrile infection related epilepsy syndrome (FIRES). The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
1. A method of treating a type of treatment-resistant epilepsy, which is Dravet syndrome, in a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising a cannabidiol (CBD) drug substance and sesame oil, wherein the CBD drug substance comprises at least 98% w/w CBD; and
wherein the dose of CBD administered to the patient ranges from about 5 mg/kg/day to about 25 mg/kg/day.
2. The method of claim 1 , wherein the CBD is synthetic.
3. The method of claim 1 , wherein the CBD drug substance comprises at least 98% w/w CBD and not more than 0.15% w/w CBDA.
4. The method of claim 1 , wherein the CBD drug substance comprises at least 98% w/w CBD and not more than 1.0% w/w CBDV.
5. The method of claim 1 , wherein the CBD drug substance comprises at least 98% w/w CBD and not more than 0.15% w/w Δ 9 THC.
6. The method of claim 1 , wherein the CBD drug substance comprises at least 98% w/w CBD and not more than 0.5% w/w CBD-C4.
7. The method of claim 1 , wherein the CBD drug substance comprises at least 98% w/w CBD, not more than 1.0% w/w CBDV, and not more than 0.15% w/w Δ 9 THC.
8. The method of claim 1 , wherein the CBD drug substance comprises at least 98% w/w CBD, not more than 1.0% w/w CBDV, not more than 0.15% w/w Δ 9 THC, and not more than 0.5% w/w CBD-C4.
9. The method of claim 1 , wherein the CBD drug substance comprises at least 98% w/w CBD, not more than 0.15% w/w CBDA, not more than 1.0% w/w CBDV, not more than 0.15% w/w Δ 9 THC, and not more than 0.5% w/w CBD-C4.
10. The method of claim 1 , wherein the administering treats convulsive seizures.
11. The method of claim 1 , wherein the administering reduces seizure frequency.
12. The method of claim 1 , wherein the administering reduces seizure frequency by at least 50% compared to a seizure frequency experienced during a baseline period before CBD was administered.
13. The method of claim 9 , wherein the administering treats convulsive seizures.
14. The method of claim 9 , wherein the administering reduces seizure frequency.
15. The method of claim 9 , wherein the administering reduces total absence seizure frequency by at least 50% compared to a seizure frequency experienced during a baseline period before CBD was administered.
16. The method of claim 1 , wherein the dose of CBD is 10 mg/kg/day.
17. The method of claim 1 , wherein the dose of CBD is 20 mg/kg/day.
18. The method of claim 16 , wherein the administering treats convulsive seizures.
19. The method of claim 16 , wherein the administering reduces seizure frequency.
20. The method of claim 16 , wherein the administering reduces seizure frequency by at least 50% compared to a frequency experienced during a baseline period before CBD was administered.
21. The method of claim 17 , wherein the administering treats convulsive seizures.
22. The method of claim 17 , wherein the administering reduces seizure frequency.
23. The method of claim 17 , wherein the administering reduces seizure frequency by at least 50% compared to a seizure frequency experienced during a baseline period before CBD was administered.
24. A method of treating a type of treatment-resistant epilepsy, which is Lennox-Gastaut syndrome, in a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising a cannabidiol (CBD) drug substance and sesame oil, wherein the CBD drug substance comprises at least 98% w/w CBD; and
wherein the dose of CBD administered to the patient ranges from about 5 mg/kg/day to about 25 mg/kg/day.
25. The method of claim 24 , wherein the administering treats convulsive seizures.
26. The method of claim 24 , wherein the administering reduces seizure frequency.
27. The method of claim 24 , wherein the administering reduces total absence seizure frequency by at least 50% compared to a seizure frequency experienced during a baseline period before CBD was administered.
28. The method of claim 24 , wherein the dose of CBD is 10 mg/kg/day.
29. The method of claim 24 , wherein the dose of CBD is 20 mg/kg/day.