Use of cannabinoids in the treatment of epilepsy

Patent metadata

Field	Value
Publication number	US-9956184-B2
Application number	US-201715449124-A
Country	US
Kind code	B2
Filing date	Mar 3, 2017
Priority date	Jun 17, 2014
Publication date	May 1, 2018
Grant date	May 1, 2018

Abstract

The present disclosure relates to the use of cannabidiol (CBD) for the reduction of total convulsive seizure frequency in the treatment of “treatment-resistant epilepsy” (TRE). In particular, the disclosure relates to the use of CBD of treating TRE when the TRE is Dravet syndrome; myoclonic absence seizures or febrile infection related epilepsy syndrome (FIRES). 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 reducing seizure frequency in a patient with a treatment-resistant epilepsy, which is Lennox-Gastaut syndrome, comprising administering to the patient in need thereof clobazam and cannabidiol (CBD), wherein the purity of the CBD is at least 98% (w/w) CBD and comprises not more than 0.15% (w/w) Δ9-tetrahydrocannabinol (THC), wherein the dose of the CBD is at least 10 mg/kg/day.

2. The method of claim 1 , wherein the administering reduces total convulsive seizure frequency.

3. The method of claim 1 , wherein the patient was administered clobazam prior to administering the combination of the CBD and the clobazam.

4. The method of claim 1 , wherein the CBD comprises 49-tetrahydrocannabinol (THC) impurity.

5. The method of claim 1 , wherein the CBD is administered at a dose of 5 mg/kg/day and increased by 2 to 5 mg/kg increments to at least 10 mg/kg/day.

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

7. The method of claim 1 , wherein the dose of the CBD is 12 mg/kg/day.

8. The method of claim 1 , wherein the dose of the CBD is 14 mg/kg/day.

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

10. The method of claim 1 , wherein the dose of the CBD is 18 mg/kg/day.

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

12. A method of treating seizures in a patient with a treatment-resistant epilepsy, which is Lennox-Gastaut syndrome, comprising administering to the patient in need thereof clobazam and cannabidiol (CBD), wherein the purity of the CBD is at least 98% (w/w) CBD and comprises not more than 0.15% (w/w) Δ9-tetrahydrocannabinol (THC), wherein the dose of the CBD is at least 10 mg/kg/day.

Assignees

• Gw Pharma Ltd

Inventors

• Guy Geoffrey
• Wright Stephen
• Mead Alice
• Devinsky Orrin

Classifications

• A61P43/00

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

• A61P25/10

  for petit-mal · CPC title

• A61P25/08

  Antiepileptics; Anticonvulsants · CPC title

• A61P25/00

  Drugs for disorders of the nervous system · CPC title

• A61K9/0053

  Mouth and digestive tract, i.e. intraoral and peroral administration · CPC title