# US 2014/0155456 A9 · Use of the phytocannabinoid cannabidiol (cbd) in combination with a standard anti-epileptic drug (saed) in the treatment of epilepsy

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- Number: US 2014/0155456 A9
- Document ID: US20140155456A9
- Status: Published application
- Kind: A9
- Application number: 13/977,766
- Filed: 2012-01-03
- Published: 2014-06-05
- Earliest claimed: 2011-01-04
- Assignees: Otsuka Pharmaceutical Co., Ltd.; GW Pharma Limited
- Inventors: Ben Whalley; Claire Williams; Gary Stephens
- Web page: https://patentgrep.com/patent/US20140155456A9

## CPC

- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61K 31/4015: having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
- A61K 31/515: Barbituric acids; Derivatives thereof, e.g. sodium pentobarbital
- A61K 36/00: Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines {(antigens from pollen A61K39/36)}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 25/08: Antiepileptics; Anticonvulsants
- 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 invention relates to the use of cannabidiol (CBD), at a dose of greater than 300 mg/day, in combination with a standard anti-epileptic drug (SAED) which acts via sodium or calcium channels, for use in the treatment of epilepsy. The SAED is preferably one which•modifies low-threshold or transient neuronal calcium currents,or•reduces high-frequency neuronal firing and sodium-dependent action potentials and enhances GABA effects. Preferred SAEDs are ethosuximide and valproate.

## Claims

### Claim 1

A method for treating epilepsy comprising administering to a subject in need thereof cannabidiol (CBD), at a dose of greater than 300 mg/day, in combination with a standard anti-epileptic drug (SAED) which acts via sodium or calcium channels.

### Claim 2

(canceled)

### Claim 3 (depends on 1)

The method of claim 1, wherein the SAED is a drug which:
modifies low-threshold or transient neuronal calcium currents, or
reduces high-frequency neuronal firing and sodium-dependent action potentials and enhances GABA effects.

### Claim 4 (depends on 1)

The method of claim 1, wherein the SAED is selected from the group consisting of: ethosuximide and valproate.

### Claim 5 (depends on 1)

The method of claim 1, wherein the type of epilepsy to be treated is generalised seizure or temporal lobe seizure.

### Claim 6 (depends on 1)

The method of claim 1, wherein the type of epilepsy to be treated is refractory to existing medication.

### Claim 7 (depends on 1)

The method of claim 1, wherein the CBD is used with one or more other therapeutically effective phytocannabinoids.

### Claim 8 (depends on 7)

The method of claim 7, wherein the one or more other therapeutically effective phytocannabinoid is THCV and/or CBDV.

### Claim 9 (depends on 1)

The method of claim 1, wherein the CBD is an isolated phytocannabinoid.

### Claim 10 (depends on 1)

The method of claim 1, wherein the CBD is in the form of a botanical drug substance.

### Claim 11

(canceled)

### Claim 12

A combination product comprising cannabidiol (CBD), at a dose of greater than 300 mg/day, and a standard anti-epileptic drug (SAED) which acts via sodium or calcium channels.