Claims
- 1. A method for treating a GI tract disorder except for acid peptic disorders or structural gastroesophageal disorders, which comprises administering to an individual in need thereof a therapeutically effective amount of an active agent wherein said agent is a sodium 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 GI tract disorder except for acid peptic disorders or structural gastroesophageal disorders would be desirable.
- 6. The method of claim 1, wherein the active agent is administered from about 0 minutes to about 3 hours prior to commencement of an activity wherein suppression of the symptoms of a GI tract disorder except for acid peptic disorders or structural gastroesophageal disorders would be desirable.
- 7. The method of claim 1, wherein the formulation is a controlled release dosage formulation.
- 8. The method of claim 1, 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 form 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 GI tract disorder is selected from the group consisting of inflammatory bowel disorders and irritable bowel syndrome.
- 27. The method of claim 26, wherein the inflammatory bowel disorder is selected from the group consisting of Crohn's disease, ulcerative colitis, collagenous colitis, lymphocytic colitis, and proctitis.
- 28. The method of claim 1, wherein said sodium channel modulator is:
a. a TTX-R sodium channel modulator, or a salt, enantiomer, analog, ester, amide, prodrug, active metabolite, and derivative thereof; or b. an activity-dependent sodium channel modulator, or a salt, enantiomer, analog, ester, amide, prodrug, active metabolite, and derivative thereof.
- 29. The method of claim 26, wherein said TTX-R sodium channel modulator is:
a. a compound that interacts with Nav1.8 channels, or a salt, enantiomer, analog, ester, amide, prodrug, active metabolite, and derivative thereof; or b. a compound that interacts with Nav1.9 channels, or a salt, enantiomer, analog, ester, amide, prodrug, active metabolite, and derivative thereof.
- 30. The method of claim 1, wherein said sodium channel modulator is Ralfinamide or a salt, enantiomer, analog, ester, amide, prodrug, active metabolite, and derivative thereof.
- 32. The method of claim 1, wherein said sodium channel modulator is Ambroxol or a salt, enantiomer, analog, ester, amide, prodrug, active metabolite, and derivative thereof.
- 33. The method of claim 1, wherein said sodium channel modulator is Sipatrigine or a salt, enantiomer, analog, ester, amide, prodrug, active metabolite, and derivative thereof.
- 34. The method of claim 1, wherein said sodium channel modulator is Lamotrigine or a salt, enantiomer, analog, ester, amide, prodrug, active metabolite, and derivative thereof.
- 35. The method of claim 2, wherein the pharmaceutical formulation further comprises an additional active agent.
- 36. The method of claim 35, 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 β3 adrenergic agonist, a neurokinin receptor antagonist, a bradykinin receptor antagonist, a nitric oxide donor, and derivatives thereof.
- 37. A pharmaceutical formulation for treating a GI tract disorder except for acid peptic disorders or structural gastroesophageal disorders adapted for transmucosal drug administration, comprising a therapeutically effective amount of a sodium 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.
- 38. A packaged kit for a patient to use in the treatment of a GI tract disorder except for acid peptic disorders or structural gastroesophageal disorders, comprising: a pharmaceutical formulation of a sodium 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 a GI tract disorder except for acid peptic disorders or structural gastroesophageal disorders.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional Application No. 60/443,731, filed Jan. 30, 2003; U.S. Provisional Application No. 60/443,730, filed Jan. 30, 2003; U.S. Provisional Application No. 60/480,565, filed Jun. 20, 2003; U.S. Provisional Application No. 60/480,598, filed Jun. 20, 2003; and U.S. Provisional Application No. 60/495,958, filed Aug. 18, 2003; all of which are hereby incorporated by reference.
Provisional Applications (5)
|
Number |
Date |
Country |
|
60443731 |
Jan 2003 |
US |
|
60443730 |
Jan 2003 |
US |
|
60480565 |
Jun 2003 |
US |
|
60480598 |
Jun 2003 |
US |
|
60495958 |
Aug 2003 |
US |