# US 7,612,096 B2 · Methods for treatment, modification and management of radiculopathy using 1-oxo-2-(2,6-dioxopiperidin-3yl)-4-aminoisoindoline

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- Number: US 7,612,096 B2
- Document ID: US7612096B2
- Status: Granted
- Kind: B2
- Application number: 10/576,152
- Filed: 2004-04-23
- Published: 2007-10-18
- Granted: 2009-11-03
- Earliest claimed: 2004-04-23
- Assignees: Celgene Corporation
- Inventors: Jerome B. Zeldis; Herbert Faleck; Donald C. Manning
- Web page: https://patentgrep.com/patent/US7612096B2

## CPC

- A61K 31/4035: Isoindoles, e.g. phthalimide
- A61K 31/135: having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)}
- A61K 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)}
- A61K 31/195: having an amino group
- A61K 31/343: condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
- A61K 31/415: 1,2-Diazoles
- A61K 31/4535: containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61K 31/60: Salicylic acid; Derivatives thereof
- A61K 31/635: having a heterocyclic ring, e.g. sulfadiazine
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- 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 of treating, preventing, modifying and managing various types of pain are disclosed. Specific methods comprise the administration of an immunomodulatory compound, or a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate, or prodrug thereof, alone or in combination with a second active agent and/or surgery, psychological or physical therapy. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.

## Claims

### Claim 1

A method of treating, modifying or managing radiculopathy, which comprises administering to a patient having radiculopathy a therapeutically effective amount of 1-oxo-2-(2,6 -dioxopiperidin-3-yl)-4-aminoisoindoline of the formula,
or a pharmaceutically acceptable salt, solvate or stereoisomer thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein the compound is 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline.

### Claim 3 (depends on 1)

The method of claim 1, wherein the compound is a pharmaceutically acceptable salt.

### Claim 4 (depends on 1)

The method of claim 1, wherein the compound is a pharmaceutically acceptable solvate.

### Claim 5 (depends on 1)

The method of claim 1, wherein the compound is a pharmaceutically acceptable stereoisomer.

### Claim 6 (depends on 5)

The method of claim 5, wherein the stereoisomer is an enantiomerically pure R isomer.

### Claim 7 (depends on 5)

The method of claim 5, wherein the stereoisomer is an enantiomerically pure S isomer.

### Claim 8 (depends on 1)

The method of claim 1, which further comprises administering a therapeutically effective amount of a second active agent.

### Claim 9 (depends on 8)

The method of claim 8, wherein the second active agent is an antidepressant, antihypertensive, anxiolytic, calcium channel blocker, alpha-adrenergic receptor agonist, alpha-adrenergic receptor antagonist, ketamine, anesthetic, muscle relaxant, non-narcotic analgesic, opioid analgesic, anti-inflammatory agent, immunomodulatory agent, immunosuppressive agent, corticosteroid, anticonvulsant, cox-2 inhibitor, hyperbaric oxygen, or a combination thereof.

### Claim 10 (depends on 8)

The method of claim 8, wherein the second active agent is salicylic acid acetate, celecoxib, ketamine, gabapentin, carbamazepine, oxcarbazepine, phenyloin, sodium valproate, prednisone, nifedipine, clonidine, oxycodone, meperidine, morphine sulfate, hydromorphone, fentanyl, acetaminophen, ibuprofen, naproxen sodium, griseofulvin, amitriptyline, imipramine or doxepin.

### Claim 11 (depends on 1)

The method of claim 1, wherein the compound is administered orally.

### Claim 12 (depends on 11)

The method of claim 11, wherein the compound is administered in the form of a capsule or tablet.

### Claim 13 (depends on 1)

The method of claim 1, wherein the compound is administered in an amount of from about 0.1 to about 150 mg per day.

### Claim 14 (depends on 1)

The method of claim 1, wherein the compound is administered in an amount of from about 5 to about 50 mg per day.

### Claim 15 (depends on 14)

The method of claim 14, wherein the compound is administered in an amount of about 5 to about 25 mg per day.

### Claim 16 (depends on 14)

The method of claim 14, wherein the compound is administered in an amount of about 25 mg per day.

### Claim 17 (depends on 14)

The method of claim 14, wherein the compound is administered in an amount of about 10 mg per day.