Use of cannabinoids in the treatment of epilepsy

Patent metadata

Field	Value
Publication number	US-11154516-B2
Application number	US-202017119873-A
Country	US
Kind code	B2
Filing date	Dec 11, 2020
Priority date	Jun 17, 2014
Publication date	Oct 26, 2021
Grant date	Oct 26, 2021

Abstract

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).

First claim

The invention claimed is:

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.

Assignees

• Gw Res Ltd

Inventors

• Guy Geoffrey
• Wright Stephen
• Devinsky Orrin

Classifications

• A61K36/3482

  Cannabis · CPC title

• A61K36/185

  Magnoliopsida (dicotyledons) · CPC title

• A61K31/658 Primary

  o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol · CPC title

• A61K31/53

  having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine (melarsoprol A61K31/555 {; with four nitrogen atoms A61K31/495}) · CPC title

• A61K31/195

  having an amino group · CPC title