FLIBANSERIN FOR THE TREATMENT OF URINARY INCONTINENCE AND RELATED DISEASES

• US 20090312242A1
• Filed: 06/27/2007
• Published: 12/17/2009
• Est. Priority Date: 06/30/2006
• Status: Abandoned Application

• Current Assignee: Sprout Pharmaceuticals, Inc. (Sprout2, Inc.)
• Original Assignee: Sprout Pharmaceuticals, Inc. (Sprout2, Inc.)
• Inventors: Castro, Ramiro, Ceci, Angelo
• Application Number:
  US12/306,878
• Publication Number:
  US 20090312242A1
• Time in Patent Office: Days
• US Class Current: 514/1.100
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/138 Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377
• CPC Class Codes: A61K 31/381 having five-membered rings
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 38/095 Oxytocins; Vasopressins; Related peptides
• CPC Class Codes: A61K 38/22 Hormones derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 13/10 of the bladder
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The invention relates to the use of Flibanserin for the treatment or prevention of urinary incontinence and related diseases. In a further embodiment, the instant invention is directed to pharmaceutical combinations comprising flibanserin as one active ingredient in combination with at least one additional active ingredient for the treatment or prevention of urinary incontinence and related diseases.

Claims

1. A method for treating or preventing urinary incontinence comprising administering a therapeutically effective amount of Flibanserin 1, or a pharmacologically acceptable acid addition salt, hydrate, or solvate thereof.

2. The method for treating or preventing urinary incontinence according to claim 1, further comprising administering and an active ingredient 2, or a pharmaceutically acceptable salt, hydrate, or solvate thereof.

3. The method for treating or preventing urinary incontinence according to claim 1, wherein the urinary incontinence is overactive bladder syndrome.

4. The method for treating or preventing urinary incontinence according to claim 2, wherein the urinary incontinence is overactive bladder syndrome.

5. The method for treating or preventing urinary incontinence according to claim 1, wherein the urinary incontinence is urgency.

6. The method for treating or preventing urinary incontinence according to claim 1, wherein the urinary incontinence is urge urinary incontinence.

7. The method for treating or preventing urinary incontinence according to claim 1, wherein the urinary incontinence is stress urinary incontinence.

8. The method for treating or preventing urinary incontinence according to claim 1, wherein the urinary incontinence is mixed urinary incontinence.

9. The method for treating or preventing urinary incontinence according to claim 2, wherein the active ingredient 2 is an antimuscarinic agent 2a, vasopressin agonist 2b, Serotonin/Noradrenaline modulator 2c, or β

3 agonist 2d.

10. The method for treating or preventing urinary incontinence according to claim 9, wherein the active ingredient 2 is an antimuscarinic agent 2a.

11. The method for treating or preventing urinary incontinence according to claim 10, wherein the antimuscarinic agent 2a is Tolterodine, Oxybutynin, Darifenacin, Propiverine, Solifenacin, or Trospium, or a pharmaceutically acceptable acid addition salt, hydrate or solvate thereof.

12. The method for treating or preventing urinary incontinence according to claim 9, wherein the active ingredient 2 is a vasopressin agonist 2b.

13. The method for treating or preventing urinary incontinence according to claim 12, wherein the vasopressin agonist 2b is desmopressin, a pharmaceutically acceptable acid addition salt, hydrate, and/or solvate thereof.

14. The method for treating or preventing urinary incontinence according to claim 9, wherein the active ingredient 2 is a Serotonin/Noradrenaline modulator 2c.

15. The method for treating or preventing urinary incontinence according to claim 14, wherein the Serotonin/Noradrenaline modulator 2c is Venlafaxine, Duloxetine, Reboxetine, or Cizoliritine, or a pharmaceutically acceptable acid addition salt, hydrate, or solvate thereof.

16. The method for treating or preventing urinary incontinence according to claim 9, wherein the active ingredient 2 is a β

3 agonist 2d.

17. The method for treating or preventing urinary incontinence according to claim 16, wherein the β

3 agonist 2d is AD9677/TAK677, CL 316,243, SB 418790, L-796568, BMS-196085, BRL-35135A, CGP12177A, BTA-243, GW 427353, Trecanidine, Zeneca D7114, SR 59119, solabegron, CL616243, 2-[4-(2-[[(1S,2R)-2-hydroxy-2-(4-hydroxyphenyl)-1-methylethyl]amino]ethyl)phenoxy]-2-methylpropionic acid, BRL37344A, or CGP-12177A, or a pharmaceutically acceptable acid addition salt, hydrate, or solvate thereof.

18. A pharmaceutical composition comprising a therapeutically effective amount of Flibanserin 1 and a therapeutically effective amount of an active ingredient 2.

19. The pharmaceutical composition according to claim 18, wherein the active ingredient 2 is an antimuscarinic agent 2a, vasopressin agonist 2b, Serotonin/Noradrenaline modulator 2c, or β

3 agonist 2d.

20. The pharmaceutical composition according to claim 19, wherein the active ingredient 2 is an antimuscarinic agent 2a.

21. The pharmaceutical composition according to claim 20, wherein the antimuscarinic agent 2a is Tolterodine, Oxybutynin, Darifenacin, Propiverine, Solifenacin, or Trospium, or a pharmaceutically acceptable acid addition salt, hydrate, or solvate.

22. The pharmaceutical composition according to claim 19, wherein the active ingredient 2 is a vasopressin agonist 2b.

23. The pharmaceutical composition according to claim 22, wherein the vasopressin agonist 2b is desmopressin, or a pharmaceutically acceptable acid addition salt, hydrate, or solvate thereof.

24. The pharmaceutical composition according to claim 19, wherein the active ingredient 2 is one or more, preferably one Serotonin/Noradrenaline modulator 1c, optionally in combination with a pharmaceutically acceptable excipient.

25. The pharmaceutical composition according to claim 24, wherein the Serotonin/Noradrenaline modulator 2c is Venlafaxine, Duloxetine, Reboxetine, or Cizoliritine, optionally in form of the or a pharmaceutically acceptable acid addition salt, hydrate, or solvate thereof.

26. The pharmaceutical composition according to claim 19, wherein the active ingredient 2 is a β

3 agonist 2d.

27. The pharmaceutical composition according to claim 26, wherein the β

3 agonist 2d is AD9677/TAK677, CL 316,243, SB 418790, L-796568, BMS-196085, BRL-35135A, CGP12177A, BTA-243, GW 427353, Trecanidine, Zeneca D7114, SR 59119, solabegron, CL616243, 2-[4-(2-[[(1S,2R)-2-hydroxy-2-(4-hydroxyphenyl)-1-methylethyl]amino]ethyl)phenoxy]-2-methylpropionic acid, BRL37344A, or CGP-12177A, or a pharmaceutically acceptable acid addition salt, hydrate, or solvate thereof.

28-29. -29. (canceled)