# US 10,765,643 B2 · Use of cannabidiol in the treatment of epilepsy

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- Number: US 10,765,643 B2
- Document ID: US10765643B2
- Status: Granted
- Kind: B2
- Application number: 15/519,233
- Filed: 2015-10-14
- Published: 2017-08-17
- Granted: 2020-09-08
- Earliest claimed: 2014-10-14
- Assignees: GW Research Limited
- Applicants: GW Pharma Limited
- Inventors: Geoffrey Guy; Stephen Wright; Orrin Devinsky
- Web page: https://patentgrep.com/patent/US10765643B2

## CPC

- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 36/3482: {Cannabis}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14)
- A61P 25/08: Antiepileptics; Anticonvulsants
- A61P 25/10: for petit-mal
- A61P 25/12: for grand-mal
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present disclosure relates to the use of cannabidiol (CBD) for the treatment of seizures associated with Aicardi Syndrome. In one embodiment the seizures associated with Aicardi Syndrome are convulsive seizures; focal seizures with impairment or infantile spasm. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).

## Claims

### Claim 1

A method of treating seizures in a subject having Aicardi Syndrome, comprising administering to the subject in need thereof cannabidiol (CBD),
wherein the CBD is present in a composition at a concentration ranging from about 25 mg/ml to about 100 mg/ml, ethanol is present in the composition at a concentration of about 79 mg/ml, sucralose at a concentration of about 0.5 mg/ml, strawberry flavoring is present in the composition at a concentration of about 0.2 mg/ml and sesame is present in the composition at an amount up to about 1.0 ml.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

The method of claim 1, wherein the seizures are convulsive seizures.

### Claim 4 (depends on 1)

The method of claim 1, wherein the seizures are focal seizures with impairment.

### Claim 5 (depends on 1)

The method of claim 1, wherein the seizures are infantile spasms.

### Claim 6 (depends on 1)

The method of claim 1, wherein the seizures are treatment resistant.

### Claim 7 (depends on 1)

The method of claim 1, wherein the CBD has a purity of at least 95% (w/w).

### Claim 8 (depends on 1)

The method of claim 1, wherein the CBD has a purity of at least 98% (w/w).

### Claim 9

A method of treating seizures in a subject having Aicardi Syndrome, comprising administering to the subject in need thereof cannabidiol (CBD) at a dose ranging from 5 mg/kg/day to 25 mg/kg/day,
wherein the CBD is present in a composition at a concentration ranging from about 25 mg/ml to about 100 mg/ml, ethanol is present in the composition at a concentration of about 79 mg/ml, sucralose at a concentration of about 0.5 mg/ml, strawberry flavoring is present in the composition at a concentration of about 0.2 mg/ml and sesame is present in the composition at an amount up to about 1.0 ml.

### Claim 10 (depends on 9)

The method of claim 9, wherein the seizures are convulsive seizures.

### Claim 11 (depends on 9)

The method of claim 9, wherein the seizures are focal seizures with impairment.

### Claim 12 (depends on 9)

The method of claim 9, wherein the seizures are infantile spasms.

### Claim 13 (depends on 9)

The method of claim 9, wherein the seizures are treatment resistant.

### Claim 14 (depends on 9)

The method of claim 9, wherein the CBD has a purity of at least 95% (w/w).

### Claim 15 (depends on 9)

The method of claim 9, wherein the CBD has a purity of at least 98% (w/w).