# US 11,998,516 B2 · Methods and compositions for treating depression using cyclobenzaprine

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,998,516 B2
- Document ID: US11998516B2
- Status: Granted
- Kind: B2
- Application number: 13/412,571
- Filed: 2012-03-05
- Published: 2012-09-13
- Granted: 2024-06-04
- Earliest claimed: 2011-03-07
- Assignees: Tonix Pharma Holdings Limited
- Applicants: Seth Lederman
- Inventors: Seth Lederman
- Web page: https://patentgrep.com/patent/US11998516B2

## CPC

- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 25/24: Antidepressants
- 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 invention relates to methods for the treatment or prevention of depression, and related pharmaceutical compositions. Of particular interest are pharmaceutical compositions comprising cyclobenzaprine, alone, or in combination with an antidepressant drug.

## Claims

### Claim 1

A method for treating a major depressive disorder in a fibromyalgia patient in need thereof, the method comprising administering to the fibromyalgia patient a pharmaceutical composition comprising cyclobenzaprine or a pharmaceutically acceptable or water-soluble salt thereof and a pharmaceutically acceptable carrier, wherein treatment with the cyclobenzaprine or salt thereof ameliorates or eliminates the major depressive disorder, and wherein the amount of cyclobenzaprine administered is less than 5 mg/day.

### Claim 2 (depends on 1)

The method of claim 1, wherein the amount of cyclobenzaprine administered is less than 2.5 mg/day.

### Claim 3 (depends on 1)

The method of claim 1, wherein the method further comprises administering the pharmaceutical composition sequentially or concurrently with an antidepressant drug.

### Claim 4 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered as an orally dissolving tablet or as a thin film formulation.

### Claim 5 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered in combination with psychotherapeutic intervention.

### Claim 6 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered at bedtime.