Methods for treatment, modification and management of radiculopathy using 1-oxo-2-(2,6-dioxopiperidin-3yl)-4-aminoisoindoline

• US 7,612,096 B2
• Filed: 04/23/2004
• Issued: 11/03/2009
• Est. Priority Date: 10/23/2003
• Status: Expired due to Fees

• Current Assignee: Celgene Corporation (Bristol-Myers Squibb Company)
• Original Assignee: Celgene Corporation (Bristol-Myers Squibb Company)
• Inventors: Manning, Donald C., Zeldis, Jerome B., Faleck, Herbert
• Primary Examiner(s): Lewis; Patrick T
• Application Number:
  US10/576,152
• Publication Number:
  US 20070244078A1
• Time in Patent Office: 2,020 Days
• Field of Search: None
• US Class Current: 514/323
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/195 having an amino group
• CPC Class Codes: A61K 31/343 condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
• CPC Class Codes: A61K 31/4035 Isoindoles, e.g. phthalimide
• CPC Class Codes: A61K 31/415 1,2-Diazoles
• CPC Class Codes: A61K 31/4535 containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/60 Salicylic acid; Derivatives thereof
• CPC Class Codes: A61K 31/635 having a heterocyclic ring, e.g. sulfadiazine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

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

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,

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

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

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

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

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

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

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

9. 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.

10. 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.

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

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

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

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

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

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

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