IP Library Granted Patent US 10,709,674
Granted Patent B2
US 10,709,674 · App. 16/678,961 · Granted Jul 14, 2020

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
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,709,674
App. No.
16/678,961
Granted
Jul 14, 2020
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 (40)

1. A method of treating seizures in a patient with Lennox-Gastaut syndrome or Dravet syndrome, comprising orally administering to the patient in need thereof cannabidiol (CBD), wherein:

(a) the CBD has a purity of at least 95% (w/w); and

(b) the CBD is administered in a composition, consisting of:

(i) CBD at a concentration ranging from about 22.5 mg/mL and about 110 mg/mL;

(ii) ethanol at a concentration ranging from about 71.1 mg/mL to about 86.9 mg/mL;

(iii) a sweetener at a concentration ranging about 0.45 mg/mL to about 0.55 mg/mL;

(iv) flavoring at a concentration ranging from about 0.18 mg/mL to about 0.22 mg/mL;

and (v) a solvent q.s. to about 1.0 ml.

2. The method according to claim 1 , wherein the sweetener is sucralose.

3. The method according to claim 1 , wherein the flavoring is strawberry flavor.

4. The method according to claim 1 , wherein the composition comprises from about 25 mg/mL to about 100 mg/mL of CBD.

5. The method of claim 1 , wherein the composition comprises about 79 mg/mL of ethanol.

6. The method of claim 2 , wherein the composition comprises about 0.5 mg/mL of sucralose.

7. The method of claim 3 , wherein the composition comprises about 0.2 mg/mL of strawberry flavoring.

8. The method of claim 1 , wherein the composition comprises about 100 mg/mL of CBD that has a purity of at least 98% (w/w).

9. The method of claim 1 , wherein the composition consists of:

(i) about 90 mg/mL to about 110 mg/mL of CBD that has a purity of at least 98% (w/w);

(ii) about 71.1 mg/mL to about 86.9 mg/mL of ethanol;

(iii) about 0.45 mg/mL to about 0.55 mg/mL of sucralose;

(iv) about 0.18 mg/mL to about 0.22 mg/mL of strawberry flavoring; and

(v) sesame oil q.s. to about 1.0 ml.

10. The method of claim 9 , wherein the composition consists of about 79 mg/mL of ethanol, about 0.5 mg/mL of sucralose, and about 0.2 mg/mL of strawberry flavoring.

11. The method of claim 1 , wherein the dose of the CBD is from about 5 mg/kg/day to about 25 mg/kg/day.

12. The method of claim 11 , wherein CBD is administered at a dose of about 5 mg/kg/day, and then the dose is increased by 2 to 5 mg/kg increments, up to a dose of about 25 mg/kg/day.

13. The method of claim 11 , wherein the dose of the CBD is about 10 mg/kg/day.

14. The method of claim 11 , wherein the dose of the CBD is about 15 mg/kg/day.

15. The method of claim 11 , wherein the dose of the CBD is about 20 mg/kg/day.

16. A method of treating seizures in a patient with Lennox-Gastaut syndrome or Dravet syndrome, comprising orally administering to the patient in need thereof cannabidiol (CBD), wherein:

(a) the CBD has a purity of at least 95% (w/w);

(b) the CBD is administered at a dose ranging from about 5 mg/kg/day to about 25 mg/kg/day.

(c) the CBD is administered in a composition, consisting of:

(i) CBD at a concentration ranging from about 22.5 mg/mL and about 110 mg/mL;

(ii) ethanol at a concentration ranging from about 71.1 mg/mL to about 86.9 mg/mL;

(iii) sucralose at a concentration ranging about 0.45 mg/mL to about 0.55 mg/mL;

(iv) strawberry flavor at a concentration ranging from about 0.18 mg/mL to about 0.22 mg/mL; and

(v) a sesame oil, q.s. to about 1.0 ml.

17. The method of claim 16 , wherein CBD is administered at a dose of about 5 mg/kg/day, and then the dose is increased by 2 to 5 mg/kg increments, up to a dose of about 25 mg/kg/day.

18. The method of claim 16 , wherein the dose of the CBD is about 10-20 mg/kg/day.

19. The method of claim 16 , wherein the CBD is at concentration ranging from about 90 mg/mL to about 110 mg/mL and that has a purity of at least 98% (w/w).

20. The method of claim 19 , wherein the composition consists essentially of about 79 mg/mL of ethanol, about 0.5 mg/mL of sucralose, and about 0.2 mg/mL of strawberry flavoring.

Assignments (4)
CHANGE OF NAME Recorded May 16, 2024
From: GW RESEARCH LIMITED
To: JAZZ PHARMACEUTICALS RESEARCH UK LIMITED
Reel/Frame 067437/0875 →
SECURITY AGREEMENT Recorded Jul 22, 2021
From: GW PHARMA LIMITED; GW RESEARCH LIMITED
To: U.S. BANK NATIONAL ASSOCIATION
Reel/Frame 056958/0493 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 20, 2020
From: GUY, GEOFFREY; WRIGHT, STEPHEN; MEAD, ALICE; DEVINSKY, ORRIN
To: GW PHARMA LIMITED
Reel/Frame 051975/0115 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 20, 2020
From: GW PHARMA LIMITED
To: GW RESEARCH LIMITED
Reel/Frame 051975/0250 →
Cited By (21)
US 12,263,139 US 12,268,699 US 12,318,356 US 12,350,253 US 12,357,586 US 12,364,670 US 12,383,512 US 12,383,567 US 12,396,963 US 12,403,136 US 12,409,131 US 12,409,132 US 12,427,160 US 12,534,438 US 12,539,472 US 12,558,362 US 12,569,505 US 12,616,705 US 12,661,365 US 12,678,450 US 12,708,632