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 seizures associated with a type of treatment-resistant epilepsy, which is Lennox-Gastaut syndrome or Dravet syndrome, in a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising a cannabidiol (CBD) drug substance, wherein the CBD drug substance comprises at least 98% w/w CBD, and the remainder of the drug substance comprises (i) not more than 0.15% w/w cannabidiolic acid (CBDA), (ii) not more than 1.0% w/w cannabidivarin (CBDV), (iii) not more than 0.15% w/w delta-9 tetrahydrocannabinol (Δ9THC), or (iv) not more than 0.5% w/w cannabidiol-C4 (CBD-C4); 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 drug substance comprises at least 98% w/w CBD and not more than 0.15% w/w CBDA.
3. 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.
4. 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 Δ9THC.
5. 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.
6. 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 Δ9THC.
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, not more than 0.15% w/w Δ9THC, and not more than 0.5% w/w CBD-C4.
8. 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 Δ9THC, and not more than 0.5% w/w CBD-C4.
9. The method of claim 1 , wherein the administering treats convulsive seizures.
10. The method of claim 1 , wherein the administering reduces seizure frequency.
11. The method of claim 1 , wherein the administering reduces total convulsive seizure frequency by at least 50% compared to the number of seizures experienced during a baseline period before CBD was administered.
12. The method of claim 8 , wherein the administering treats convulsive seizures.
13. The method of claim 8 , wherein the administering reduces seizure frequency.
14. The method of claim 8 , wherein the administering reduces total convulsive seizure frequency by at least 50% compared to the number of seizures experienced during a baseline period before CBD was administered.
15. The method of claim 1 , wherein the dose of the CBD is about 10 mg/kg/day.
16. The method of claim 1 , wherein the dose of the CBD is about 20 mg/kg/day.
17. The method of claim 15 , wherein the administering treats convulsive seizures.
18. The method of claim 15 , wherein the administering reduces seizure frequency.
19. The method of claim 15 , wherein the administering reduces convulsive seizure frequency by at least 50% compared to the number of seizures experienced during a baseline period before CBD was administered.
20. The method of claim 16 , wherein the administering treats convulsive seizures.
21. The method of claim 16 , wherein the administering reduces seizure frequency.
22. The method of claim 16 , wherein the administering reduces convulsive seizure frequency by at least 50% compared to the number of seizures experienced during a baseline period before CBD was administered.
23. The method of claim 1 , wherein the treatment-resistant epilepsy is Lennox-Gastaut syndrome, and wherein the dose of the CBD is about 10 mg/kg/day or about 20 mg/kg/day.
24. The method of claim 23 , wherein the patient's convulsive seizure frequency is reduced by at least 50% compared to the number of seizures experienced during a baseline period before CBD was administered.
25. The method of claim 23 , wherein the dose of the CBD is about 10 mg/kg/day.
26. The method of claim 23 , wherein the dose of the CBD is about 20 mg/kg/day.
27. The method of claim 1 , wherein the treatment-resistant epilepsy is Dravet syndrome, and wherein the dose of the CBD is about 10 mg/kg/day or about 20 mg/kg/day.
28. The method of claim 27 , wherein the patient's convulsive seizure frequency is reduced by at least 50% compared to the number of seizures experienced during a baseline period before CBD was administered.
29. The method of claim 27 , wherein the dose of the CBD is about 10 mg/kg/day.
30. The method of claim 27 , wherein the dose of the CBD is about 20 mg/kg/day.