Granted Patent B2

US 12,661,365 · App. 18/002,437 · Granted Jun 23, 2026

Inventors: Jie Li (Carlsbad, CA); Kevin James Craig (Sittingbourne, GB); Daniel Adam Checketts (Sittingbourne, GB); David John Critchley (Sittingbourne, GB)

Assignee: JAZZ PHARMACEUTICALS RESEARCH UK LIMITED

A61K31/658A61K31/522

Abstract

Claims (23)

1 . A method of treating childhood-onset epilepsy in a patient in need thereof,

comprising administering to the patient a pharmaceutical composition comprising a cannabidiol (CBD) drug substance comprising at least 98% w/w CBD, wherein the patient is taking caffeine concurrently;

wherein the dose of caffeine is reduced compared to a patient that is not taking CBD concurrently, wherein the dose of caffeine is reduced to lower than 200 mg/day.

2 . The method of claim 1 , wherein the dose of caffeine is reduced no more than 95 mg/day.

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

4 . The method of claim 1 , wherein the dose of caffeine is reduced to no more than 50 mg/day.

5 . The method of claim 1 , wherein the CBD drug substance comprises not more than 0.15% w/w CBDA.

6 . 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.

7 . 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.

8 . 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.

9 . 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.

10 . 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.

11 . 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.

12 . The method of claim 1 , wherein the childhood-onset epilepsy is selected from the group consisting of Lennox-Gastaut Syndrome; Myoclonic Absence Epilepsy; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Jeavons Syndrome; CDKL5; Dup15q; Neuronal ceroid lipofuscinoses (NCL) and brain abnormalities.

13 . The method of claim 1 , wherein the childhood-onset epilepsy is Lennox-Gastaut Syndrome.

14 . The method of claim 1 , wherein the childhood-onset epilepsy is Dravet Syndrome.

15 . The method of claim 1 , wherein the childhood-onset epilepsy is Tuberous Sclerosis Complex.

16 . A method of treating childhood-onset epilepsy in a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising a cannabidiol (CBD) drug substance, wherein the patient is taking caffeine concurrently; and wherein the dose of CBD is in the range of about 5 mg/kg/day to about 20 mg/kg/day, and the dose of caffeine is lower than 200 mg/day.

17 . The method of claim 16 , 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 A9THC, and not more than 0.5% w/w CBD-C4.

18 . The method of claim 16 , wherein the childhood-onset epilepsy is selected from the group consisting of Lennox-Gastaut Syndrome; Myoclonic Absence Epilepsy; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Jeavons Syndrome; CDKL5; Dup15q; Neuronal ceroid lipofuscinoses (NCL) and brain abnormalities.

19 . The method of claim 16 , wherein the childhood-onset epilepsy is Lennox-Gastaut Syndrome.

20 . The method of claim 16 , wherein the childhood-onset epilepsy is Dravet Syndrome.

21 . The method of claim 16 , wherein the childhood-onset epilepsy is Tuberous Sclerosis Complex.

Assignments (3)

Priority Claims (1)

Continuity (1)

References Cited (400)