Use of cannabinoids in the treatment of epilepsy

Patent metadata

Field	Value
Publication number	US-11701330-B2
Application number	US-202117472016-A
Country	US
Kind code	B2
Filing date	Sep 10, 2021
Priority date	Jun 17, 2014
Publication date	Jul 18, 2023
Grant date	Jul 18, 2023

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 and testing liver function,
wherein the CBD drug substance comprises at least 98% w/w CBD, and
wherein the CBD is administered at a starting dose of about 5 mg/kg/day, and then the dose is increased by increments of about 5 mg/kg.

2. The method of claim 1 , wherein the dose of CBD is increased up to a maximum of about 25 mg/kg/day.

3. The method of claim 1 , wherein the dose of CBD is increased to about 10 mg/kg/day.

4. The method of claim 1 , wherein the dose of CBD is increased to about 20 mg/kg/day.

5. The method of claim 1 , wherein the dose of CBD is increased to a dose ranging from about 10 mg/kg/day to about 20 mg/kg/day.

6. The method of claim 1 , wherein the CBD is synthetic.

7. The method of claim 1 , wherein the CBD drug substance comprises not more than 0.15% w/w Δ 9 THC.

8. The method of claim 1 , wherein the CBD drug substance comprises 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 convulsive seizures experienced during a baseline period before CBD was administered.

12. The method of claim 3 , wherein the administering treats convulsive seizures.

13. The method of claim 3 , wherein the administering reduces seizure frequency.

14. The method of claim 3 , wherein the administering reduces convulsive seizure frequency by at least 50% compared to the number of convulsive seizures experienced during a baseline period before CBD was administered.

15. The method of claim 4 , wherein the administering treats convulsive seizures.

16. The method of claim 4 , wherein the administering reduces seizure frequency.

17. The method of claim 4 , wherein the administering reduces convulsive seizure frequency by at least 50% compared to the number of convulsive seizures experienced during a baseline period before CBD was administered.

18. The method of claim 1 , wherein the type of treatment-resistant epilepsy is Lennox-Gastaut syndrome, and the dose of the CBD is increased to about 10 mg/kg/day or about 20 mg/kg/day.

19. The method of claim 18 , wherein the patient's convulsive seizure frequency is reduced by at least 50% compared to the number of convulsive seizures experienced during a baseline period before CBD was administered.

20. The method of claim 18 , wherein the dose of the CBD is increased to about 10 mg/kg/day.

21. The method of claim 18 , wherein the dose of the CBD is increased to about 20 mg/kg/day.

22. The method of claim 1 , wherein the type of treatment-resistant epilepsy is Dravet syndrome, and the dose of the CBD is increased to about 10 mg/kg/day or about 20 mg/kg/day.

23. The method of claim 22 , wherein the patient's convulsive seizure frequency is reduced by at least 50% compared to the number of convulsive seizures experienced during a baseline period before CBD was administered.

24. The method of claim 22 , wherein the dose of the CBD is increased to about 10 mg/kg/day.

25. The method of claim 22 , wherein the dose of the CBD is increased to about 20 mg/kg/day.

26. The method of claim 1 , wherein the testing is performed at baseline.

27. The method of claim 1 , wherein the testing is performed after administering the CBD drug substance.

28. The method of claim 27 , wherein the testing is performed 4 weeks or 12 weeks after initiating treatment.

29. The method of claim 1 , wherein the testing is performed at baseline and after administering the CBD drug substance.

30. The method of claim 29 , wherein the testing is performed after 4 weeks or 12 weeks of treatment.

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

• A61K31/05 Primary

  Phenols {(cannabinoids A61K31/658)} · CPC title

• A61K9/0053

  Mouth and digestive tract, i.e. intraoral and peroral administration · CPC title