Methods of treating non-painful bladder disorders using alpha2delta subunit calcium channel modulators

• US 20040142034A1
• Filed: 12/19/2003
• Published: 07/22/2004
• Est. Priority Date: 12/20/2002
• Status: Abandoned Application

• Current Assignee: Dynogen Pharmaceuticals, Inc. (Edusa Pharmaceuticals, Inc.)
• Original Assignee: Dynogen Pharmaceuticals, Inc. (Edusa Pharmaceuticals, Inc.)
• Inventors: Thor, Karl Bruce, Fraser, Matthew Oliver, Burgard, Edward C.
• Application Number:
  US10/741,360
• Publication Number:
  US 20040142034A1
• Time in Patent Office: Days
• US Class Current: 424/468
• CPC Class Codes: A61K 31/195 having an amino group
• 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: 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 13/08 of the prostate
• 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

A method is provided for treatment of non-painful bladder disorders, particularly non-painful overactive bladder without loss of urine. The method comprises administration of an α₂δ subunit calcium channel modulator, including gabapentin, pregabalin, GABA analogs, fused bicyclic or tricyclic amino acid analogs of gabapentin, amino acid compounds, and other compounds that interact with the α₂δ calcium channel subunit.

Claims

1. A method for treating OAB Dry, which comprises administering to an individual in need thereof a therapeutically effective amount of an active agent wherein said agent is an α

₂δ

subunit calcium channel modulator or a pharmaceutically acceptable salt, ester, amide, prodrug, or active metabolite thereof.

2. The method of claim 1, wherein the active agent is contained within a pharmaceutical formulation.

3. The method of claim 2, wherein the pharmaceutical formulation is a unit dosage formulation.

4. The method of claim 1, wherein the active agent is administered on an as-needed basis.

5. The method of claim 1, wherein the active agent is administered prior to commencement of an activity wherein suppression of the symptoms of a non-painful bladder disorder without loss of urine would be desirable.

6. The method of claim 5, wherein the active agent is administered from about 0 to about 3 hours prior to commencement of an activity wherein suppression of the symptoms of said non-painful bladder disorder would be desirable.

7. The method of claim 2, wherein the formulation is a controlled release dosage formulation.

8. The method of claim 7, wherein the formulation is a delayed release dosage formulation.

9. The method of claim 7, wherein the formulation is a sustained release dosage formulation.

10. The method of claim 8, wherein the formulation is a sustained release dosage formulation.

11. The method of claim 9, wherein the sustained release dosage formulation provides drug release over a time period of from about 6 hours to about 8 hours.

12. The method of claim 1, wherein the active agent is administered orally.

13. The method of claim 2, wherein the active agent is administered orally.

14. The method of claim 13, wherein the pharmaceutical formulation is selected from the group consisting of tablets, capsules, caplets, solutions, suspensions, syrups, granules, beads, powders and pellets.

15. The method of claim 1, wherein the active agent is administered transmucosally.

16. The method of claim 15, wherein the active agent is administered sublingually.

17. The method of claim 15, wherein the active agent is administered buccally.

18. The method of claim 15, wherein the active agent is administered intranasally.

19. The method of claim 15, wherein the active agent is administered transurethrally.

20. The method of claim 15, wherein the active agent is administered rectally.

21. The method of claim 15, wherein the active agent is administered by inhalation.

22. The method of claim 1, wherein the active agent is administered topically.

23. The method of claim 1, wherein the active agent is administered transdermally.

24. The method of claim 1, wherein the active agent is administered parenterally.

25. The method of claim 1, wherein the active agent is administered intrathecally.

26. The method of claim 1, wherein the active agent is selected from the group consisting of:

a. Gabapentin;

b. Pregabalin; and

c. Derivatives and analogs thereof.

27. The method of claim 26, wherein gabapentin is administered in an amount from about 600 mg to about 2400 mg per day.

28. The method of claim 2, wherein the pharmaceutical formulation further comprises an additional active agent.

29. The method of claim 28, wherein the additional active agent is selected from the group consisting of:

a tricyclic antidepressant, duloxetine, venlafaxine, a monoamine reuptake inhibitor, gabapentin, pregabalin, a 5-HT₃ antagonist, a 5-HT₄ antagonist, and derivatives and analogs thereof.

30. A method for treating a non-painful bladder disorder without loss of urine, which comprises administering to an individual in need thereof a therapeutically effective amount of an active agent wherein said agent is an α

₂δ

subunit calcium channel modulator or a pharmaceutically acceptable salt, ester, amide, prodrug, or active metabolite thereof.

31. A pharmaceutical formulation for treating a non-painful bladder disorder without loss of urine and adapted for transmucosal drug administration, comprising a therapeutically effective amount of an α

₂δ

subunit type calcium channel modulator, or a pharmaceutically acceptable salt, ester, amide, prodrug, or active metabolite thereof, and a carrier suitable for transmucosal drug delivery buccally, sublingually, intranasally, rectally, or by inhalation, wherein the α

₂δ

subunit type calcium channel modulator is gabapentin and is administered in an amount from about 600 mg to about 2400 mg per day.

32. A packaged kit for a patient to use in the treatment of non-painful bladder disorders without loss of urine, comprising:

a pharmaceutical formulation of an α

₂δ

subunit calcium channel modulator;

a container housing the pharmaceutical formulation during storage and prior to administration; and

instructions for carrying out drug administration in a manner effective to treat non-painful bladder disorders without loss of urine.