Use of cannabinoids in the treatment of Angelman syndrome

Patent metadata

Field	Value
Publication number	US-11679087-B2
Application number	US-201716467639-A
Country	US
Kind code	B2
Filing date	Dec 13, 2017
Priority date	Dec 16, 2016
Publication date	Jun 20, 2023
Grant date	Jun 20, 2023

Abstract

The present invention relates to the use of cannabidiol (CBD) in the treatment of Angelman syndrome (AS). CBD has been shown to be particularly effective in improving anxiety in rodent models of AS. The CBD is preferably substantially pure. It may take the form of a highly purified extract of Cannabis such that the CBD is present at greater than 98% of the total extract (w/w) and the other components of the extract are characterised. Alternatively, the CBD is synthetically produced. Alternatively, the CBD may be used as a botanical drug substance (BDS) from a Cannabis plant in which CBD is the predominant cannabinoid. The CBD may also be present in combination with other cannabinoids and non-cannabinoid components such as terpenes. In use the CBD may be used concomitantly with one or more other medicaments. Alternatively, the CBD may be formulated for administration separately, sequentially or simultaneously with one or more medicaments or the combination may be provided in a single dosage form. Where the CBD is formulated for administration separately, sequentially or simultaneously it may be provided as a kit or together with instructions to administer the one or more components in the manner indicated. It may also be used as the sole medication, i.e. as a monotherapy.

First claim

The invention claimed is:

1. A method for treating anxiety associated with Angelman syndrome, comprising orally administering to a subject in need thereof a therapeutically effective amount of a cannabidiol (CBD) drug substance, wherein the CBD drug substance comprises at least 98% (w/w) CBD and the CBD is administered at a dose of 20 mg/kg/day.

2. The method of claim 1 , wherein the CBD drug substance is administered in combination with one or more concomitant medications.

3. The method of claim 1 , wherein the CBD drug substance is administered in combination with at least one anti-epileptic drug (AED).

4. The method of claim 1 , wherein the CBD drug substance is an extract of Cannabis.

5. The method of claim 4 , wherein the extract comprises less than 0.15% THC.

6. The method of claim 1 , wherein the CBD is a synthetic compound.

7. The method of claim 1 , further comprising treating a movement disorder.

8. The method of claim 1 , further comprising treating cognitive dysfunction.

9. A method for treating anxiety associated with Angelman syndrome, comprising orally administering to a subject in need thereof a therapeutically effective amount of cannabidiol (CBD), wherein:
the CBD is an extract of Cannabis which comprises at least 98% (w/w) CBD and less than 0.15% THC; and
the CBD is administered at a dose of 20 mg/kg/day.

10. The method of claim 1 , wherein the CBD drug substance comprises greater than 98.5% (w/w) CBD.

11. The method of claim 10 , wherein the CBD is an extract of Cannabis.

12. The method of claim 1 , further comprising treating seizures.

13. The method of claim 10 , wherein the CBD is a synthetic compound.

14. The method of claim 1 , wherein the CBD drug substance comprises greater than 99% (w/w) CBD.

15. The method of claim 14 , wherein the CBD is an extract of Cannabis.

16. The method of claim 15 , wherein the extract comprises less than 0.15% THC.

17. The method of claim 9 , further comprising treating a movement disorder.

18. The method of claim 9 , further comprising treating cognitive dysfunction.

19. The method of claim 9 , further comprising treating seizures.

Assignees

• Gw Res Ltd

Inventors

• Guy Geoffrey
• Wright Stephen
• Brodie James
• Woolley-Roberts Marie
• Luongo Livio

Classifications

• A61K36/185

  Magnoliopsida (dicotyledons) · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61P25/20

  Hypnotics; Sedatives · CPC title

• A61K31/05 Primary

  Phenols {(cannabinoids A61K31/658)} · CPC title

• A61K36/3482

  Cannabis · CPC title