# US 2013/0158121 A1 · Methods for treating vasomotor symptoms using gaba analogs in a gastric retentive dosage form

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- Number: US 2013/0158121 A1
- Document ID: US20130158121A1
- Status: Published application
- Kind: A1
- Application number: 13/686,865
- Filed: 2012-11-27
- Published: 2013-06-20
- Earliest claimed: 2008-02-11
- Assignees: Depomed, Inc.
- Inventors: Bret Berner; Sui Yuen Eddie Hou; Theophilus J. Gana; Marilou S. Cramer; Carl A. Pelzel
- Web page: https://patentgrep.com/patent/US20130158121A1

## CPC

- A61K 31/195: having an amino group
- A61K 9/0065: {Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus}
- A61K 9/2031: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- 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

Methods for treating vasomotor symptoms associated with menopause are described.

## Claims

### Claim at position 1

-34. (canceled)

### Claim 35

A titration regimen for treating a subject experiencing menopause-related vasomotor symptoms, comprising:
administering a first total daily dose of gabapentin in a dosage form for a first time period;
administering a second total daily dose of gabapentin in the dosage form for a second time period;
wherein the second total daily dose is greater than the first total daily dose; and
wherein the dosage form comprises a hydrophilic polymer, wherein after administration the dosage form swells to a size that is retained in the stomach of the subject.

### Claim 36 (depends on 35)

The regimen of claim 35, further comprising administering a third total daily dose of gabapentin in the dosage form for a third period of time.

### Claim 37 (depends on 35)

The regimen of claim 35, wherein administering the first total daily dose of gabapentin comprises administering the first total daily dose once per day.

### Claim 38 (depends on 37)

The regimen of claim 37, wherein the first total daily dose is administered in the evening.

### Claim 39 (depends on 35)

The regimen of claim 35, wherein the first total daily dose is between about 600 mg and 1200 mg.

### Claim 40 (depends on 35)

The regimen of claim 35, wherein the first total daily dose is about 600 mg.

### Claim 41 (depends on 35)

The regimen of claim 35, wherein the first period of time is about 1 to 3 days.

### Claim 42 (depends on 35)

The regimen of claim 35, wherein the first period of time is about 3 days.

### Claim 43 (depends on 35)

The regimen of claim 35, wherein administering the second total daily dose comprises administering the second total daily dose once per day.

### Claim 44 (depends on 43)

The regimen of claim 43, wherein the second total daily dose is administered in the evening.

### Claim 45 (depends on 35)

The regimen of claim 35, wherein the second total daily dose is between about 800 mg and 1500 mg.

### Claim 46 (depends on 35)

The regimen of claim 35, wherein the second total daily dose is about 1200 mg.

### Claim 47 (depends on 35)

The regimen of claim 35, wherein the second period of time is between about 2 to 4 days.

### Claim 48 (depends on 35)

The regimen of claim 35, wherein the second period of time is about 3 days.

### Claim 49 (depends on 36)

The regimen of claim 36, wherein the third total daily dose is administered as a first and a second dose.

### Claim 50 (depends on 36)

The regimen of claim 36, wherein the third total daily dose is between about 600 mg and 2400 mg.

### Claim 51 (depends on 36)

The regimen of claim 36, wherein the third total daily dose is about 1800 mg.

### Claim 52 (depends on 49)

The regimen of claim 49, wherein the first dose is 600 mg administered in the morning and the second dose is 1200 mg administered in the evening.

### Claim 53 (depends on 36)

The regimen of claim 36, wherein the third period of time is 2 or more days.