TREATMENT OF RHINITIS

• US 20140294737A1
• Filed: 10/05/2012
• Published: 10/02/2014
• Est. Priority Date: 10/07/2011
• Status: Abandoned Application

• Current Assignee: Ampio Pharmaceuticals, Inc.
• Original Assignee: Ampio Pharmaceuticals, Inc.
• Inventors: Bar-Or, David
• Application Number:
  US14/349,412
• Publication Number:
  US 20140294737A1
• Time in Patent Office: Days
• US Class Current: 424/45
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61M 11/02 operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised sprayers for horticulture A01G, A01H; killing insects A01M; air humidifying by nozzles F24F6/14, F24F6/18; cooling by spraying F28B, F28C
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

The invention provides a method of treating rhinitis. The method comprises administering an effective amount of a danazol compound or a pharmaceutically acceptable salt thereof. The invention also provides a pharmaceutical product formulated for nasal administration. The product comprises a danazol compound or a pharmaceutically acceptable salt thereof.

Claims

1. A method of treating rhinitis comprising administering an effective amount of a danazol compound or a pharmaceutically acceptable salt thereof, to an animal in need thereof.

2. The method of claim 1, wherein the rhinitis is allergic rhinitis.

3. The method of claim 1, wherein the effective amount of the danazol compound or the pharmaceutically acceptable salt thereof is from about 100 μ

g to about 3000 μ

g per day.

4. The method of claim 1, wherein the effective amount of the danazol compound or the pharmaceutically acceptable salt thereof is from about 500 μ

g to about 1500 μ

g per day.

5. The method of claim 1, wherein administration of the danazol compound or a pharmaceutically acceptable salt thereof, is commenced within 24 hours of diagnosis of rhinitis.

6. The method of claim 1, wherein administration of the danazol compound or a pharmaceutically acceptable salt thereof, is commenced at the appearance of one or more early signs of, or a predisposition to develop, rhinitis.

7. The method of claim 6, wherein the one or more early signs of rhinitis are selected from the group consisting of rhinorrhea, nasal congestion, nasal itching and sneezing.

8. The method of claim 1, wherein the danazol compound is danazol.

9. The method of claim 1, wherein the danazol compound or a pharmaceutically acceptable salt thereof is administered in combination with a second drug suitable for treating rhinitis.

10. The method of claim 9, wherein the second drug suitable for treating rhinitis is selected from the group consisting of antihistamines, decongestants, anti-inflammatories, mast cell stabilizers, leukotriene modifiers and IgE blockers.

11. A pharmaceutical product, comprising a danazol compound or a pharmaceutically-acceptable salt thereof formulated for administration by a route selected from the group consisting of inhalation, insufflation and nasal administration to the nose.

12. The pharmaceutical product of claim 11, wherein the danazol compound or a pharmaceutically-acceptable salt thereof formulated for administration by inhalation is packaged in a device selected from the group consisting of insufflators, nebulizers, pressurized packs, squeeze bottle, a syringe, a dropper, a spray device, an atomizer device, and an aerosolizer.

13. The pharmaceutical product of claim 12, wherein the pressurized pack comprises a propellant selected from the group consisting of dichlorodifluoromethane, trichlorofluoromethane, dichlorotetrafluoroethane, and carbon dioxide.

14. The pharmaceutical product of claim 11, wherein the danazol compound or a pharmaceutically-acceptable salt thereof formulated for administration by inhalation or insufflation comprises a powder mix of the danazol compound or pharmaceutically-acceptable salt thereof and a powder base.

15. The pharmaceutical product of claim 14, wherein the powder mix is in a dosage form selected from the group consisting of capsules, cartridges, gelatin packs and blister packs.

16. The pharmaceutical product of claim 15, wherein the powder mix is delivered by a device selected from the group consisting of an inhalator, insufflator and metered-dose inhaler.

17. The pharmaceutical product of claim 11, wherein the danazol compound or a pharmaceutically-acceptable salt thereof formulated for nasal administration is in a form of drops or sprays.

18. The pharmaceutical product of claim 17, wherein the danazol compound or a pharmaceutically-acceptable salt thereof comprises about 0.1% (w/v).

19. The pharmaceutical product of claim 17, wherein the drops or sprays are contained within an intranasal delivery system.

20. The pharmaceutical product of claim 17, wherein the intranasal delivery system comprises an atomizing device.

21. The pharmaceutical product of claim 20, wherein the atomizing device comprises a bottle and a pump.

22. The pharmaceutical product of claim 21, wherein the pump is a metered dose pump.

23. The pharmaceutical product of claim 22, wherein the metered dose pump delivers an intranasal volume of the danazol compound or a pharmaceutically-acceptable salt thereof of about 0.15 ml per pump.

24. The pharmaceutical product of claim 17, further comprising an aqueous or non-aqueous base comprising one or more agents selected from the group consisting of dispersing agents, solubilizing agents, and suspending agents.

25. The pharmaceutical product of claim 11, wherein the danazol compound or a pharmaceutically-acceptable salt thereof formulated for nasal administration is in a form selected from the group consisting of ointments, gels and creams.

26. The pharmaceutical product of claim 25, wherein the danazol compound or a pharmaceutically-acceptable salt thereof further comprises excipients selected from the group consisting of animal fats, vegetable fats, oils, waxes, paraffins, starch, tragacanth, cellulose derivatives, polyethylene glycol, silicones, bentonites, silicic acid, talc, zinc oxide and mixtures thereof.

27. The pharmaceutical product of claim 11, further comprising an absorption or permeation enhancer.

28. The pharmaceutical product of claim 11, further comprising a thickening agent or viscosity enhancer to increase the residence time of the danazol compound or pharmaceutically-acceptable salt thereof in the nose.

29. The pharmaceutical product of claim 11, further comprising a pharmaceutically-acceptable carrier.

30. The pharmaceutical product of claim 11, wherein the danazol compound is danazol.