IP Library Granted Patent US 11,446,258
Granted Patent B2
US 11,446,258 · App. 17/477,172 · Granted Sep 20, 2022

Use of cannabinoids in the treatment of epilepsy

Inventors: Geoffrey Guy (London, GB); Stephen Wright (London, GB); Orrin Devinsky (New York, NY)
Assignee: GW Research Limited
A61K31/05A61K9/08A61K31/352A61K45/06A61K47/10
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Quick Facts
Patent No.
US 11,446,258
App. No.
17/477,172
Granted
Sep 20, 2022
Kind
B2
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).

Claims (29)

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.

Assignments (4)
SECURITY AGREEMENT Recorded Jul 26, 2024
From: CAVION, INC.; CELATOR PHARMACEUTICALS, INC.; GW PHARMA LIMITED; JAZZ PHARMACEUTICALS, INC.; JAZZ PHARMACEUTICALS IRELAND LIMITED; JAZZ PHARMACEUTICALS RESEARCH UK LIMITED (F/K/A GW RESEARCH LIMITED)
To: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION, AS COLLATERAL TRUSTEE
Reel/Frame 068173/0155 →
CHANGE OF NAME Recorded May 16, 2024
From: GW RESEARCH LIMITED
To: JAZZ PHARMACEUTICALS RESEARCH UK LIMITED
Reel/Frame 067437/0875 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 8, 2022
From: GUY, GEOFFREY; WRIGHT, STEPHEN; DEVINSKY, ORRIN
To: GW PHARMA LIMITED
Reel/Frame 060463/0975 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 29, 2021
From: GW PHARMA LIMITED
To: GW RESEARCH LIMITED
Reel/Frame 058256/0880 →