Milnacipran for the long-term treatment of fibromyalgia syndrome

• US 7,994,220 B2
• Filed: 09/26/2006
• Issued: 08/09/2011
• Est. Priority Date: 09/28/2005
• Status: Active Grant

• Current Assignee: Forest Laboratories Holdings Limited (Abbvie Incorporated)
• Original Assignee: Cypress Systems Incorporated (Logisteed Limited)
• Inventors: Gendreau, Michael, Kranzler, Jay D., Rao, Srinivas G.
• Primary Examiner(s): Padmanabhan; Sreeni
• Assistant Examiner(s): CLAYTOR, DEIRDRE RENEE
• Application Number:
  US11/535,237
• Publication Number:
  US 20070072946A1
• Time in Patent Office: 1,778 Days
• Field of Search: 514/579, 514/765
• US Class Current: 514/579
• 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 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/197 the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid carnitine A61K31/205
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/06 Antimigraine agents
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention is directed to methods for providing long-term treatment of fibromyalgia syndrome (FMS) by administering a dual re-uptake inhibitor to a patient with FMS. More particularly, the present invention is directed to the long-term treatment of FMS by administering a norepinephrine-serotonin reuptake inhibitor (NSRI) to a patient with FMS.

Claims

1. A method of treating fibromyalgia in a patient suffering from fibromyalgia comprising administering milnacipran, or a pharmaceutically acceptable salt thereof, to the patient according to the following schedule:

a) administering 12.5 mg milnacipran/day to the patient for 1 day;

then

b) administering 25 mg milnacipran/day to the patient for 2 days;

then

c) administering 50 mg milnacipran/day to the patient for 4 days;

then

d) administering 100 mg milnacipran/day.

2. The method of claim 1, wherein the milnacipran or a salt thereof is administered in a tablet dosage form.

3. The method of claim 2, wherein the tablet dosage form comprises an amount of milnacipran selected from 12.5 mg, 25 mg, 50 mg, or 100 mg.

4. The method of claim 1, wherein the milnacipran in steps b) to d) is administered twice daily.

5. The method of claim 1, wherein the milnacipran in step b) is administered as a 12.5 mg dosage two times per day.

6. The method of claim 1, wherein the milnacipran in step c) is administered as a 25 mg dosage two times per day.

7. The method of claim 1, wherein the milnacipran in step d) is administered as a 50 mg dosage two times per day.