IP Library Granted Patent US 12,318,356
Granted Patent B2
US 12,318,356 · App. 18/186,792 · Granted Jun 3, 2025

Use of cannabinoids in the treatment of epilepsy

Inventors: Geoffrey Guy (Cambridge, GB); Stephen Wright (Altrincham, GB); Orrin Devinsky (New York, NY)
Assignee: Jazz Pharmaceuticals Research UK Limited
A61K31/05A61K9/08A61K31/352A61K45/06A61K47/10
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Quick Facts
Patent No.
US 12,318,356
App. No.
18/186,792
Granted
Jun 3, 2025
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 (27)

1. A method of treating a typical absence seizure 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

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 reduces the number of typical absence seizures compared to baseline.

10. The method of claim 1 , wherein the administering reduces typical absence seizure frequency compared to baseline.

11. The method of claim 1 , wherein the administering reduces typical absence seizure frequency by at least 50% compared to the typical absence seizure frequency experienced during a baseline period before CBD was administered.

12. The method of claim 8 , wherein the administering reduces the number of typical absence seizures compared to baseline.

13. The method of claim 8 , wherein the administering reduces typical absence seizure frequency compared to baseline.

14. The method of claim 8 , wherein the administering reduces typical absence seizure frequency by at least 50% compared to the typical absence seizure frequency experienced during a baseline period before CBD was administered.

15. The method of claim 1 , wherein the dose of CBD is 10 mg/kg/day.

16. The method of claim 1 , wherein the dose of CBD is 20 mg/kg/day.

17. The method of claim 15 , wherein the administering reduces the number of typical absence seizures compared to baseline.

18. The method of claim 15 , wherein the administering reduces typical absence seizure frequency compared to baseline.

19. The method of claim 15 , wherein the administering reduces typical absence seizure frequency by at least 50% compared to the typical absence seizure frequency experienced during a baseline period before CBD was administered.

20. The method of claim 16 , wherein the administering reduces typical absence seizures compared to baseline.

21. The method of claim 16 , wherein the administering reduces typical absence seizure frequency compared to baseline.

22. The method of claim 16 , wherein the administering reduces typical absence seizure frequency by at least 50% compared to the typical absence seizure frequency experienced during a baseline period before CBD was administered.

23. The method of claim 1 , wherein the dose of CBD administered to the patient ranges from about 10 mg/kg/day to about 20 mg/kg/day.

24. The method of claim 23 , wherein the administering reduces the number of typical absence seizures compared to baseline.

25. The method of claim 23 , wherein the administering reduces typical absence seizure frequency compared to baseline.

26. The method of claim 23 , wherein the administering reduces typical absence seizure frequency by at least 50% compared to the typical absence seizure frequency 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 067437/0870 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 26, 2023
From: GW PHARMA LIMITED
To: GW RESEARCH LIMITED
Reel/Frame 063459/0701 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 7, 2023
From: GUY, GEOFFREY; WRIGHT, STEPHEN; DEVINSKY, ORRIN
To: GW PHARMA LIMITED
Reel/Frame 063262/0778 →
Cited By (2)
US 12,569,505 US 12,661,365