Methods of treating fibromyalgia

• US 20030130353A1
• Filed: 12/19/2001
• Published: 07/10/2003
• Est. Priority Date: 11/05/2001
• Status: Active Grant

• Current Assignee: Forest Laboratories Holdings Limited (Abbvie Incorporated)
• Original Assignee: Cypress Systems Incorporated (Logisteed Limited)
• Inventors: Kranzler, Jay D., Rao, Srinivas G.
• Granted Patent: US 6,602,911 B2
• Time in Patent Office: Days
• US Class Current: 514/620
• 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 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61P 19/04 for non-specific disorders of the connective tissue
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

Abstract

The present invention provides a method of treating fibromyalgia syndrome (FMS), chronic fatigue syndrome (CFS), and pain in an animal subject. The method generally involves administering a therapeutically effective amount of a dual serotonin norepinephrine reuptake inhibitor compound or a pharmaceutically acceptable salt thereof, wherein said dual serotonin norepinephrine reuptake inhibitor compound is characterized by a non-tricyclic structure and an equal or greater inhibition of norepinephrine reuptake than serotonin reuptake. In particular, the use of milnacipran to treat FMS, CFS, and pain is disclosed.

Claims

1. A method of treating fibromyalgia syndrome (FMS) and/or physiological symptoms associated therewith in an animal subject, comprising administering to an animal subject suffering from FMS, an effective amount of milnacipran, or a pharmaceutically acceptable salt thereof.

2. The method according to claim 1, wherein the milnacipran is not administered adjunctively with phenylalanine, tyrosine or tryptophan.

3. The method according to claim 1, wherein FMS is treated.

4. The method according to claim 1, wherein symptoms associated with FMS are treated.

5. The method according to claim 1, wherein the compound is adjunctively administered with antidepressants, analgesics, muscle relaxants, anorectics, stimulants, antiepileptic drugs, sedatives, or hypnotics.

6. The method according to claim 1, wherein the compound is adjunctively administered with neurontin, pregabalin, pramipexole, 1-DOPA, amphetamine, tizanidine, clonidine, tramadol, morphine, codeine, carbamazepine, sibutramine, amphetamine, valium, or trazodone.

7. The method according to claim 1, wherein the animal subject is a human.

8. The method according to claim 1, wherein the amount administered is from about 25 mg to about 400 mg per day.

9. The method according to claim 1, wherein the milnacipran is formulated in a sustained release dosage formulation.

24. A kit comprising a milnacipran or a pharmaceutically acceptable salt thereof and instructions teaching a method of use according to any one of claims 1, 10 or 17.

25. The kit of claim 24 in which the milnacipran or salt thereof is packaged in unit dosage form.

10. A method of treating pain in an animal subject, comprising administering to an animal subject suffering from pain, an effective amount of milnacipran, or a pharmaceutically acceptable salt thereof.

11. The method according to claim 10, wherein the milnacipran is not administered adjunctively with phenylalanine, tyrosine or tryptophan.

12. The method according to claim 10, wherein the compound is adjunctively administered with antidepressants, analgesics, muscle relaxants, anorectics, stimulants, antiepileptic drugs, sedatives, or hypnotics.

13. The method according to claim 10, wherein the compound is adjunctively administered with neurontin, pregabalin, pramipexole, 1-DOPA, amphetamine, tizanidine, clonidine, tramadol, morphine, a tricyclic antidepressant, codeine, carbamazepine, sibutramine, amphetamine, valium, or trazodone.

14. The method according to claim 10, wherein the animal subject is a human.

15. The method according to claim 10, wherein the amount administered is from about 25 mg to about 400 mg per day.

16. The method according to claim 10, wherein the compound is formulated in a sustained release dosage formulation.

17. A method of treating chronic fatigue syndrome (CFS) and/or physiological symptoms associated therewith in an animal subject, comprising administering to an animal subject suffering from CFS, an effective amount of milnacipran, or a pharmaceutically acceptable salt thereof.

18. The method according to claim 17, wherein the milnacipran is not administered adjunctively with phenylalanine, tyrosine or tryptophan.

19. The method according to claim 17, wherein the compound is adjunctively administered with antidepressants, analgesics, muscle relaxants, anorectics, stimulants, antiepileptic drugs, sedatives, or hypnotics.

20. The method according to claim 17, wherein the compound is adjunctively administered with neurontin, pregabalin, pramipexole, 1-DOPA, amphetamine, tizanidine, clonidine, tramadol, morphine, a tricyclic antidepressant, codeine, carbamazepine, sibutramine, amphetamine, valium, or trazodone.

21. The method according to claim 17, wherein the animal subject is a human.

22. The method according to claim 17, wherein the amount administered is from about 25 mg to about 400 mg per day.

23. The method according to claim 17, wherein the compound is formulated in a sustained release dosage formulation.