Methods of treating mammals with eustachian tube dysfunctions

• US 8,642,631 B2
• Filed: 05/27/2009
• Issued: 02/04/2014
• Est. Priority Date: 05/27/2008
• Status: Active Grant

• Current Assignee: Otolanum Ag
• Original Assignee: University of Melbourne
• Inventors: Anderson, Colin Russell, Franz, Burkhard
• Primary Examiner(s): Weddington, Kevin E
• Application Number:
  US12/994,709
• Publication Number:
  US 20110166190A1
• Time in Patent Office: 1,714 Days
• Field of Search: 514/357
• 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. A method for treating Eustachian tube dysfunction comprising topically applying to a Eustachian tube of a patient in need thereof an effective amount of betahistine or a salt thereof, wherein the betahistine is formulated for use as nose drops, eye drops, or a metered nasal spray.

2. A method according to claim 1 wherein the betahistine or a salt thereof is administered to a nasal mucosa nasopharynx or an opening of the Eustachian tubes.

3. A method according to claim 1 wherein the betahistine or a salt thereof is administered at a concentration of betahistine (calculated from free-base) between 0.1 mg/mL to 50 mg/mL.

4. A method according to claim 1 wherein the Eustachian tube dysfunction is Otitis Media (OM).

5. A method according to claim 1 wherein the Eustachian tube dysfunction is Otitis Media with Effusion (OME).

6. A method according to claim 1 wherein the patient is a human child.

7. A method according to claim 1 wherein the Eustachian tube dysfunction is Acute Otitis Media (AOM) or Aerotitis Media (AM).

8. A method according to claim 1 wherein the betahistine is in a salt form.

9. A method according to claim 8 wherein the betahistine is in the dihydrochloric acid salt form.

10. A method according to claim 1 wherein the betahistine or a salt thereof is administered at a concentration of betahistine (calculated from free-base) of up to 10 mg/mL.

11. A method according to claim 1 further comprising administering a further pharmaceutically active agent.

12. A method of claim 11 wherein the further pharmaceutically active agent is a mucolytic or decongestant.

13. A method comprising topically administering to a patient in need thereof an effective amount of betahistine or a salt thereof, wherein the betahistine is formulated for use as nose drops, eye drops, or a metered nasal spray.

14. A method according to claim 13 wherein the betahistine or a salt thereof is administered at a concentration of betahistine (calculated from free-base) between 0.1 mg/mL to 50 mg/mL.

15. A method according to claim 14 wherein the betahistine or a salt thereof is administered at a concentration of betahistine (calculated from free-base) of up to 10 mg/mL.

16. A method according to claim 13 wherein the betahistine is in a salt form.

17. A method according to claim 16 wherein the betahistine is in the dihydrochloric acid salt form.

18. A method according to claim 13 further comprising administering a further pharmaceutically active agent.

19. A method of claim 18 wherein the further pharmaceutically active agent is a mucolytic or decongestant.