METHODS OF TREATING MAMMALS WITH EUSTACHIAN TUBE DYSFUNCTIONS

• US 20110166190A1
• Filed: 05/27/2009
• Published: 07/07/2011
• Est. Priority Date: 05/27/2008
• Status: Active Grant

• Current Assignee: Otolanum Ag
• Original Assignee: University of Melbourne
• Inventors: Anderson, Colin Russell, Franz, Burkhard
• Granted Patent: US 8,642,631 B2
• Time in Patent Office: Days
• US Class Current: 514/357
• CPC Class Codes: A61K 31/4402 only substituted in position 2, e.g. pheniramine, bisacodyl
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61P 1/08 for nausea, cinetosis or vertigo; Antiemetics
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 27/16 Otologicals

Abstract

The invention relates to methods of medically treating mammals with Eustachian tube dysfunctions, such as Ménière'"'"'s disease, vertigo, Otitis Media (including Otitis Media with Effusion (OME), Acute Otitis Media (AOM) and Aerotitis Media (AM)) as well as other disorders which are characterized by ET dysfunction.

Claims

1-35. -35. (canceled)

36. A method for treating Eustachian tube dysfunction including the step of topically applying to a patient an effective amount of betahistine.

37. A method according to claim 36 wherein the betahistine is administered to the nasal mucosa nasopharynx or the openings of the Eustachian tubes.

38. A method according to claim 36 wherein the betahistine is administered at a concentration of between 0.1 mg/mL to 50 mg/mL applied within the nasopharynx.

39. A method according to claim 36 wherein the Eustachian tube dysfunction is Otitis Media (OM).

40. A method according to claim 36 wherein the Eustachian tube dysfunction is Otitis Media with Effusion (OME).

41. A method according to claim 36 wherein the patient is a human child.

42. A method according to claim 36 wherein the Eustachian tube dysfunction is Acute Otitis Media (AOM) or Aerotitis Media (AM).

43. A topical composition comprising betahistine for the treatment of Eustachian tube dysfunction.

46. A topical composition according to claim 43 or claim 44 further comprising at least one pharmaceutically acceptable carrier, diluent or excipient, wherein the concentration of betahistine (calculated from free-base)/carrier, diluent or excipient is 0.1 mg/mL to 50 mg/mL.

47. A topical composition according to claim 43 or claim 44 comprising a further pharmaceutically active agent, which is a mucolytic or decongestant.

44. A topical composition comprising betahistine in the form of nose drops or a metered nasal spray for the treatment of Eustachian tube dysfunctions.

45. A topical composition according to claim 44 wherein the betahistine is in the dihydrochloric acid salt form.