# US 2014/0194428 A1 · Combination treatments for bipolar disorders

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- Number: US 2014/0194428 A1
- Document ID: US20140194428A1
- Status: Published application
- Kind: A1
- Application number: 13/573,640
- Filed: 2012-09-28
- Published: 2014-07-10
- Earliest claimed: 2012-09-28
- Assignees: Elan Pharmaceuticals, Inc.
- Inventors: Susan Abushakra; Gerald Crans; Ramon Hernandez; Jesse Cedarbaum
- Web page: https://patentgrep.com/patent/US20140194428A1

## CPC

- A61K 31/53: having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine (melarsoprol A61K31/555 {; with four nitrogen atoms A61K31/495})
- A61K 31/20: having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61K 31/7004: Monosaccharides having only carbon, hydrogen and oxygen atoms
- 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)

## Abstract

The invention relates generally to novel compositions and methods comprising a scyllo-inositol compound and one or both of valproic acid compound and lamotrigine. The compositions and methods provide beneficial effects in the treatment of bipolar disorders.

## Claims

### Claim 1

A method of delaying the occurrence of a mood episode in a subject having bipolar disorder comprising administering to said subject effective amounts of scyllo-inositol and one or both of valproic acid and lamotrigine.

### Claim 2

A method of reducing the level of myo-inositol in the brain of a subject comprising administering to the subject effective amounts of scyllo-inositol and one or both of valproic acid and lamotrigine.

### Claim 3

A method for treating a bipolar disorder comprising administering to the subject a combination of an effective amount of scyllo-inositol and an effective amount of one or both of a valproic acid compound and lamotrigine.

### Claim 4 (depends on 3)

The method as claimed in claim 3 wherein the bipolar disorder is bipolar I disorder.

### Claim 5 (depends on 1, 2, 3)

The method as claimed in any one of claims 1 to 3 wherein the effective amounts of scyllo-inositol and one or both of valproic acid and lamotrigine are combined and administered to the subject in a single formulation.

### Claim 6 (depends on 1, 2, 3)

The method as claimed in any one of claims 1 to 3 wherein the effective amounts of the scyllo-inositol compound and one or both of a valproic acid compound and lamotrigine are administered to the subject sequentially.

### Claim 7 (depends on 1, 2, 3)

The method as claimed in any one of claims 1 to 3, wherein the subject is administered an effective amount of scyllo-inositol and an effective amount of valproic acid and not lamotragine.

### Claim 8 (depends on 7)

The method as claimed in claim 7, wherein valproic acid is administered to the subject prior to scyllo-inositol.

### Claim 9 (depends on 8)

The method as claimed in claim 8, wherein the concentration of valproic acid in the subject's plasma is about 1 to 500 μg/mL.

### Claim 10 (depends on 8)

The method as claimed in claim 8, wherein the concentration of valproic acid in the subject's plasma is about 50 to 125 μg/mL.

### Claim 11 (depends on 8)

The method as claimed in claim 8, wherein the concentration of valproic acid in the subject's plasma is between 50 and 125 μg/mL.

### Claim 12 (depends on 6)

The method as claimed in claim 6, wherein the combination administered to the subject is an effective amount of scyllo-inositol and an effective amount of lamotrigine and not valproic acid.

### Claim 13 (depends on 12)

The method as claimed in claim 12, wherein lamotrigine is administered to the subject prior to scyllo-inositol.

### Claim 14 (depends on 13)

The method as claimed in claim 13, wherein the concentration of lamotrigine in the subject's plasma is about 1 to 500 μg/mL.

### Claim 15 (depends on 13)

The method as claimed in claim 13, wherein the concentration of lamotrigine in the subject's plasma is about 10 to 50 μg/mL.

### Claim 16 (depends on 13)

The method as claimed in claim 13, wherein the concentration of lamotrigine in the subject's plasma is between 10 and 50 μg/mL.

### Claim 17 (depends on 1, 2, 3)

The method as claimed in any one of claims 1 to 3, wherein the amount of scyllo-inositol administered to the subject is from 1 to 5,000 mg/day.

### Claim 18 (depends on 17)

The method as claimed in claim 17 wherein the amount of scyllo-inositol administered to the subject is from 100 to 2,000 mg/day.

### Claim 19 (depends on 17)

The method as claimed in claim 17 wherein the amount of scyllo-inositol administered to the subject is 1,000 mg/day.

### Claim 20 (depends on 17)

The method as claimed in claim 17 wherein the amount of scyllo-inositol administered to the subject is 500 mg BID.

### Claim 21 (depends on 12)

The method as claimed in claim 12 wherein the amount of scyllo-inositol administered is 500 mg BID and the concentration of valproic acid in the subject's plasma is is between 50 and 125 μg/mL.

### Claim 22 (depends on 17)

The method as claimed in claim 17 wherein the amount of scyllo-inositol administered is 500 mg BID and the concentration of lamotrigine in the subject's plasma is between 10 and 50 μg/mL.

### Claim 23 (depends on 1)

The method as claimed in claim 1 wherein the effective amounts of the scyllo-inositol compound and one or both of a valproic acid compound and lamotrigine are synergistically effective amounts.

### Claim 24

A pharmaceutical composition for treating a bipolar disorder comprising a scyllo-inositol compound and one or both of a valproic acid compound and lamotrigine.

### Claim 25 (depends on 24)

The pharmaceutical composition according to claim 24 comprising about 100 to about 1500 mg of the scyllo-inositol compound.

### Claim 26

Use of a scyllo-inositol compound and one or both of a valproic acid compound and lamotrigine for the treatment of a bipolar disorder.

### Claim 27

A kit comprising a scyllo-inositol compound and one or both of a valproic acid compound and lamotrigine, a container, and instructions for use in the treatment of a bipolar disorder in a subject.
