Methods of treating gastrointestinal tract disorders using sodium channel modulators

• US 7,041,704 B2
• Filed: 02/11/2005
• Issued: 05/09/2006
• Est. Priority Date: 01/30/2003
• 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): KIM, VICKIE Y
• Application Number:
  US11/057,024
• Publication Number:
  US 20050203190A1
• Time in Patent Office: 452 Days
• Field of Search: 514/727, 514/730, 514/741
• US Class Current: 514/727
• 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 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/506 not condensed and containing further heterocyclic rings
• CPC Class Codes: A61K 31/53 having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine melarsoprol A61K31/555 ; with four nitrogen atoms A61K31/495
• 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

Abstract

The invention relates to methods of using sodium channel modulators, particularly TTX-R sodium channel modulators and/or activity dependent sodium channel modulators to treat a gastrointestinal tract disorders, particularly inflammatory bowel disorders and irritable bowel syndrome.

Claims

1. A method for treating a functional gastrointestinal tract disorder, which comprises administering to an individual in need thereof a therapeutically effective amount of ambroxol or a pharmaceutically acceptable salt, enantiomer, analog, ester, amide, prodrug, metabolite, or derivative thereof wherein said functional gastrointestinal tract disorder is selected from the group consisting of irritable bowel syndrome, slow-transit constipation, non-ulcer dyspepsia, an evacuation disorder and functional dysphasia.

2. The method of claim 1, wherein said functional gastrointestinal tract disorder is irritable bowel syndrome.

3. The method of claim 1, wherein said functional gastrointestinal tract disorder is slow-transit constipation.

4. The method of claim 1, wherein said functional gastrointestinal tract disorder is non-ulcer dyspepsia.

5. The method of claim 1, wherein said functional gastrointestinal tract disorder is an evacuation disorder.

6. The method of claim 1, wherein said functional gastrointestinal tract disorder is functional dysphagia.

7. The method of claim 1, wherein said ambroxol or a pharmaceutically acceptable salt, enantiomer, analog, ester, amide, prodrug, metabolite, or derivative thereof is administered orally, transmucosally, sublingually, buccally, intranasally, transurethrally, rectally, by inhalation, topically, transdermally, parenterally, or intrathecally.

8. The method of claim 1, wherein said ambroxol or a pharmaceutically acceptable salt, enantiomer, analog, ester, amide, prodrug, metabolite, or derivative thereof is administered concurrently with an additional active agent.

9. The method of claim 8, wherein the additional active agent is selected from the group consisting of an antispasmodic, a tricyclic antidepressant, duloxetine, venlafaxine, a monoamine 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, a nitric oxide donor, and derivatives thereof.