Use of cannabinoids in the treatment of epilepsy

Patent metadata

Field	Value
Publication number	US-11446258-B2
Application number	US-202117477172-A
Country	US
Kind code	B2
Filing date	Sep 16, 2021
Priority date	Oct 14, 2014
Publication date	Sep 20, 2022
Grant date	Sep 20, 2022

Abstract

The present disclosure relates to the use of cannabidiol (CBD) for the treatment of atonic seizures. In particular the CBD appears particularly effective in reducing atonic seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Aicardi syndrome; CDKL5 and Dup15q in comparison to other seizure types. 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 in a patient having Lennox-Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex, or Doose Syndrome comprising orally administering to the patient a pharmaceutical formulation comprising cannabidiol (CBD), wherein the CBD is present in the pharmaceutical formulation at a concentration of about 100 mg/mL, and wherein the patient is administered a starting dose of CBD of about 5 mg/kg/day, and after administering the starting dose, the starting dose of CBD is gradually increased by about 5 mg/kg increments up to a maximum of about 25 mg/kg/day.

2. The method of claim 1 , wherein the starting dose of CBD is increased to a dose ranging from about 10 mg/kg/day to about 25 mg/kg/day.

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

4. The method of claim 1 , wherein the starting dose of CBD is increased to about 15 mg/kg/day.

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

6. The method of claim 1 , wherein the starting dose of CBD is increased to about 25 mg/kg/day.

7. The method of claim 1 , wherein the seizures are atonic seizures, tonic seizures, clonic seizures, tonic-clonic seizures, absence seizures, or myoclonic seizures.

8. The method of claim 2 , wherein the seizures are atonic seizures, tonic seizures, clonic seizures, tonic-clonic seizures, absence seizures, or myoclonic seizures.

9. The method of claim 3 , wherein the seizures are atonic seizures, tonic seizures, clonic seizures, tonic-clonic seizures, absence seizures, or myoclonic seizures.

10. The method of claim 4 , wherein the seizures are atonic seizures, tonic seizures, clonic seizures, tonic-clonic seizures, absence seizures, or myoclonic seizures.

11. The method of claim 5 , wherein the seizures are atonic seizures, tonic seizures, clonic seizures, tonic-clonic seizures, absence seizures, or myoclonic seizures.

12. The method of claim 6 , wherein the seizures are atonic seizures, tonic seizures, clonic seizures, tonic-clonic seizures, absence seizures, or myoclonic seizures.

13. The method of claim 1 , comprising treating seizures in a patient having Lennox-Gastaut syndrome.

14. The method of claim 13 , wherein the starting dose of CBD is increased to a dose ranging from about 10 mg/kg/day to about 20 mg/kg/day.

15. The method of claim 13 , wherein the starting dose of CBD is increased to about 10 mg/kg/day.

16. The method of claim 13 , wherein the starting dose of CBD is increased to about 20 mg/kg/day.

17. The method of claim 1 , comprising treating seizures in a patient having Dravet syndrome.

18. The method of claim 17 , wherein the starting dose of CBD is increased to a dose ranging from about 10 mg/kg/day to about 20 mg/kg/day.

19. The method of claim 17 , wherein the starting dose of CBD is increased to about 10 mg/kg/day.

20. The method of claim 17 , wherein the starting dose of CBD is increased to about 20 mg/kg/day.

21. The method of claim 1 , comprising treating seizures in a patient having Tuberous Sclerosis Complex.

22. The method of claim 21 , wherein the starting dose of CBD is increased to a dose ranging from about 10 mg/kg/day to about 25 mg/kg/day.

23. The method of claim 21 , wherein the starting dose of CBD is increased to about 25 mg/kg/day.

24. The method of claim 1 , comprising treating seizures in a patient having Doose Syndrome.

25. The method of claim 24 , wherein the starting dose of CBD is increased to a dose ranging from about 10 mg/kg/day to about 25 mg/kg/day.

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

27. The method of claim 24 , wherein the starting dose of CBD is increased to about 20 mg/kg/day.

28. The method of claim 24 , wherein the starting dose of CBD is increased to about 25 mg/kg/day.

29. The method of claim 1 , wherein the administering reduces the number of seizures by at least 50% compared to the number of seizures experienced during a baseline period before CBD was administered.

Assignees

• Gw Res Ltd

Inventors

• Guy Geoffrey
• Wright Stephen
• Devinsky Orrin

Classifications

• A61K36/185

  Magnoliopsida (dicotyledons) · CPC title

• A61K31/658 Primary

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

• A61K9/08

  Solutions {(composition of solutions A61K47/00)} · CPC title

• A61K2300/00

  Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00 · CPC title

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title