Methods of treating non-inflammatory gastrointestinal tract disorders using Cav2.2 subunit calcium channel modulators

• US 7,125,848 B2
• Filed: 06/10/2004
• Issued: 10/24/2006
• Est. Priority Date: 06/13/2003
• Status: Expired due to Fees

• Current Assignee: Edusa Pharmaceuticals, Inc.
• Original Assignee: Dynogen Pharmaceuticals, Inc. (Edusa Pharmaceuticals, Inc.)
• Inventors: Landau, Steven B., Fraser, Matthew Oliver, Burgard, Edward C.
• Primary Examiner(s): Wax, Robert A.
• Assistant Examiner(s): Mitra, Rita
• Application Number:
  US10/865,225
• Publication Number:
  US 20050026835A1
• Time in Patent Office: 866 Days
• Field of Search: 530/350, 514/12
• US Class Current: 424/718
• 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 31/4015 having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
• CPC Class Codes: A61K 31/4422 1,4-Dihydropyridines, e.g. nifedipine, nicardipine
• CPC Class Codes: A61K 31/455 Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
• CPC Class Codes: A61K 31/4706 4-Aminoquinolines; 8-Aminoquinolines, e.g. chloroquine, primaquine
• CPC Class Codes: A61K 31/5377 not condensed and containing further heterocyclic rings, e.g. timolol
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• 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: C07K 5/06043 Leu-amino acid
• CPC Class Codes: C07K 5/06078 and aromatic or cycloaliphatic

Abstract

A method is provided for using Cav2.2 subunit calcium channel modulators to treat non-inflammatory gastrointestinal tract disorders.

Claims

1. A method for treating a symptom of a non-inflammatory GI tract disorder, comprising administering a therapeutically effective amount of a Cav2.2 subunit calcium channel modulator selected from the group consisting of:

a. ω

-conotoxin GVIA; and

b. ω

-conotoxin MVIIA (Ziconotide).

2. The method of claim 1, wherein said Cav2.2 subunit calcium channel modulator is contained within a pharmaceutical formulation.

3. The method of claim 1, wherein said Cav2.2 subunit calcium channel modulator is administered on an as-needed basis.

4. The method of claim 3, wherein said Cav2.2 subunit calcium channel modulator is administered prior to commencement of an activity wherein suppression of the symptoms of a non-inflammatory GI tract disorder would be desirable.

5. The method of claim 4, wherein said Cav2.2 subunit calcium channel modulator is administered from about 0 to about 5 hours prior to commencement of an activity wherein suppression of said symptoms would be desirable.

6. The method of claim 4, wherein said Cav2.2 subunit calcium channel modulator 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 1, wherein said Cav2.2 subunit calcium channel modulator is administered orally, transmucosally, sublingually, buccally, intranasally, transurethrally, rectally, by inhalation, topically, transdermally, parenterally, or intrathecally.

8. The method of claim 1, wherein the symptom of a non-inflammatory GI tract disorder is associated with a functional GI tract disorder selected from the group consisting of functional dysphagia, non-ulcer dyspepsia, irritable bowel syndrome, slow-transit constipation, and an evacuation disorder.

9. The method of claim 1, wherein the symptom of a non-inflammatory GI tract disorder is associated with a motor disorder of the esophagus selected from the group consisting of achalasia and diffuse esophageal spasm.

10. The method of claim 1, wherein the symptom of a non-inflammatory GI tract disorder is associated with a non-inflammatory structural GI disorder selected from the group consisting of hiatal hernia, stricture, esophageal web, Schatzki'"'"'s ring, esophageal diverticulum, and esophageal scleroderma.

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

12. The method of claim 11, wherein the additional active agent is selected from the group consisting of:

an antiulcerative, an antidiarrheal, a peristaltic colon stimulant, an antispasmodic, an antinauseant/prokinetic, an anti-inflammatory bowel drug, a tricyclic antidepressant, a ketolaric, duloxetine, venlafaxine, a selective serotonin reuptake inhibitor, a serotonin/norepinephrine reuptake inhibitor, a spasmolytic, an anticholinergic, gabapentin, pregabalin, a substituted aminomethyl-phenyl-cyclohexane derivative, a 5-HT₃ antagonist, a 5-HT₄ antagonist, a β

3 adrenergic agonist, a neurokinin receptor antagonist, a bradykinin receptor antagonist, and a nitric oxide donor.

13. A pharmaceutical composition comprising a Cav2.2 subunit calcium channel modulator in a therapeutically effective amount sufficient to treat a symptom of a non-inflammatory GI tract disorder, wherein said Cav2.2 subunit calcium channel modulator is selected from the group consisting of:

a. ω

-conotoxin GVIA; and

b. ω

-conotoxin MVIIA (Ziconotide),

wherein the pharmaceutical formulation further comprises an additional active agent.

14. The pharmaceutical composition of claim 13, wherein the additional active agent is selected from the group consisting of:

an antiulcerative, an antidiarrheal, a peristaltic colon stimulant, an antispasmodic, an antinauseant/prokinetic, an anti-inflammatory bowel drug, a tricyclic antidepressant, a ketolaric, duloxetine, venlafaxine, a selective serotonin reuptake inhibitor, a serotonin/norepinephrine reuptake inhibitor, a spasmolytic, an anticholinergic, gabapentin, pregabalin, a substituted aminomethyl-phenyl-cyclohexane derivative, a 5-HT₃ antagonist, a 5-HT₄ antagonist, a β

3 adrenergic agonist, a neurokinin receptor antagonist, a bradykinin receptor antagonist, and a nitric oxide donor.