Methods for treating or preventing fibromyalgia using very low doses of cyclobenzaprine

• US 6,541,523 B2
• Filed: 06/27/2001
• Issued: 04/01/2003
• Est. Priority Date: 08/13/1999
• Status: Expired due to Term

• Current Assignee: Krele Pharmaceuticals, Inc. (Tonix Pharmaceuticals Holding Corp.)
• Original Assignee: Vela Pharmaceuticals Inc. (W World Corp.)
• Inventors: Iglehart, Iredell W. III
• Primary Examiner(s): Fay, Zohreh
• Assistant Examiner(s): KWON, YONG SOK
• Application Number:
  US09/893,758
• Publication Number:
  US 20010046988A1
• Time in Patent Office: 643 Days
• Field of Search: 514/656, 514/654, 514/239.2, 514/249, 514/220, 514/270, 514/253, 514/646, 514/649, 514/452
• US Class Current: 514/654
• 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 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• 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 25/20 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 37/02 Immunomodulators

Abstract

The present invention relates to methods and compositions comprising a very low dose of cyclobenzaprine or metabolite thereof for preventing and treating sleep disturbances and illnesses manifested with sleep dysfunction including fibromyalgia syndrome, chronic fatigue syndrome, sleep disorders, psychogenic pain disorders or chronic pain syndromes or symptoms thereof. The present invention further relates to methods and compositions for treating sleep disturbances, chronic pain or fatigue in humans suffering from fibromyalgia syndrome, chronic fatigue syndrome, sleep disorders, psychogenic pain disorders, chronic pain syndromes using a very low dose of cyclobenzaprine.

Claims

1. A method for treating or preventing fibromyalgia comprising the step of administering to a human in need of treatment for fibromyalgia cyclobenzaprine or a metabolite thereof in an amount of less than 2.5 mg/day.

2. The method according to claim 1, wherein cyclobenzaprine or metabolite thereof is administered in an amount of 1.0 mg or less per day.

3. The method according to claim 1, wherein cyclobenzaprine or metabolite thereof is administered in one dose before bedtime.

4. The method according to claim 1, wherein cyclobenzaprine or metabolite thereof is administered in combination with psychotherapy.

5. The method according to claim 1, wherein cyclobenzaprine or metabolite thereof is administered in combination with light-box therapy.

6. The method according to claim 1, wherein cyclobenzaprine or metabolite thereof is administered in combination with a second therapeutic agent selected from the group consisting of a TCA, an SSRI, an atypical antidepressant, an SNRI, an NRIS, an anti-inflammatory, and an analgesic.

7. The method according to claim 1, wherein cyclobenzaprine is administered as a hydrochloride salt.

8. The method according to claim 6, wherein the second therapeutic agent is administered sequentially or concurrently with said cyclobenzaprine or metabolite thereof.

9. The method according to claim 6, wherein the TCA is selected from the group consisting of imipramine, trimipramine, nortriptyline, amitriptyline, doxepin, protriptyline, clomipramine and desipramine.

10. The method according to claim 6, wherein the SSRI is selected from the group consisting of fluoxetine, fluvoxamine maleate, paroxetine, sertraline, and citalopram.

11. The method according to claim 6, wherein the atypical antidepressant is selected from the group consisting of serotonin agonist and reuptake inhibitors (SARIs);

norepinephrine-dopamine reuptake inhibitors (NDRIs);

norepinephrine reuptake inhibitors (NRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs).

12. The method according to claim 1, wherein the cyclobenzaprine or metabolite thereof is administered orally or parentally.

13. The method according to claim 1, wherein the cyclobenzaprine or pharmaceutically acceptable salt thereof is administered as a tablet or a capsule.

14. The method according to claim 11, wherein the atypical antidepressant is nefazodone (Serzone™

) or trazodone (Desyrel™

).

15. The method according to claim 11, wherein the atypical antidepressant is bupropion (Wellbutrin™

).

16. The method according to claim 11, wherein the atypical antidepressant is reboxetine (Edronax™

).

17. The method according to claim 11, wherein the atypical antidepressant is venlafaxine (Effexor™

), amoxapine or maprotiline.

18. The method according to claim 1, wherein cyclobenzaprine or metabolite thereof is administered at bedtime.

19. The method according to claim 1, wherein cyclobenzaprine or metabolite thereof is administered several hours before bedtime.