Methods for treating lower urinary tract disorders and the related disorders vulvodynia and vulvar vestibulitis using Cav2.2 subunit calcium channel modulators

• US 7,084,116 B2
• Filed: 03/10/2004
• Issued: 08/01/2006
• Est. Priority Date: 03/10/2003
• Status: Expired due to Fees

• Current Assignee: Edusa Pharmaceuticals, Inc.
• Original Assignee: Dynogen Pharmaceuticals, Inc. (Edusa Pharmaceuticals, Inc.)
• Inventors: Thor, Karl Bruce, Fraser, Matthew Oliver, Burgard, Edward C.
• Primary Examiner(s): Campell, Bruce R.
• Assistant Examiner(s): GUDIBANDE, SATYANARAYAN R
• Application Number:
  US10/796,952
• Publication Number:
  US 20040198775A1
• Time in Patent Office: 874 Days
• Field of Search: None
• US Class Current: 514/17.4
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/455 Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system

Abstract

The invention relates to methods of using Cav2.2 subunit calcium channel modulators to treat painful and non-painful lower urinary tract disorders and the related genitourinary tract disorders vulvodynia and vulvar vestibulitis in normal and spinal cord injured patients.

Claims

1. A method for treating overactive bladder, which comprises orally administering to an individual in need thereof a therapeutically effective amount of an active agent wherein said agent is Ziconotide (ω

-conotoxin MVIIA) or a pharmaceutically acceptable salt, ester, amide, prodrug, active metabolite or derivative 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 overactive bladder 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 said symptoms 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 9, wherein the sustained release dosage formulation provides drug release over a time period of from about 6 hours to about 8 hours.

11. The method of claim 1, wherein said overactive bladder is OAB Wet.

12. The method of claim 1, wherein said overactive bladder is OAB Dry.

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

14. The method of claim 13, wherein the additional active agent is ω

-conotoxin GVIA or a salt, enantiomer, analog, ester, amide, prodrug, active metabolite, or derivative thereof.