IP Library Granted Patent US 10,548,907
Granted Patent B2
US 10,548,907 · App. 14/682,001 · Granted Feb 4, 2020

Treatment of allergic rhinitis using a combination of mometasone and olopatadine

Inventors: Neelima Khairatkar-Joshi (Thane, IN); Abhay Kulkarni (Navi Mumbai, IN); Dinesh Pradeep Wale (District-Osmanabad, IN); Vikram Mansingh Bhosale (Mumbai, IN); Piyush Agarwal (Mumbai, IN); Patrick Keohane (London, GB); Sudeesh K. Tantry (Jamison, PA); Chad Oh (Mahwah, NJ)
Assignee: Glenmark Specialty S.A.
A61K31/58A61K9/0043A61K31/335
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Quick Facts
Patent No.
US 10,548,907
App. No.
14/682,001
Granted
Feb 4, 2020
Kind
B2
Abstract

The present invention relates to a method of treating allergic rhinitis in a subject (e.g., a human) in need thereof comprising nasally administering to the subject an effective amount of a fixed-dose pharmaceutical composition comprising mometasone or its salt and olopatadine or its salt.

Claims (32)

1. A method of treating one or more symptoms associated with allergic rhinitis in a human subject in need thereof comprising twice daily nasal administration to the human subject of about 1330 mcg per nostril of olopatadine hydrochloride and about 50 mcg per nostril of mometasone furoate, wherein (i) the olopatadine hydrochloride and mometasone furoate are administered in a single pharmaceutical composition as a nasal spray, and (ii) the twice daily administration of the pharmaceutical composition provides a faster onset of action than twice daily administration of 1330 mcg per nostril of olopatadine hydrochloride alone.

2. The method according to claim 1 , wherein each administration of the composition is two sprays of the composition in each nostril, and each spray comprises about 25 mcg mometasone furoate and about 665 mcg olopatadine hydrochloride.

3. The method according to claim 1 , wherein the pharmaceutical composition is a suspension comprising mometasone furoate in particulate form and olopatadine in dissolved form.

4. The method according to claim 1 , wherein the allergic rhinitis is perennial allergic rhinitis.

5. The method according to claim 1 , wherein the allergic rhinitis is seasonal allergic rhinitis.

6. The method according to claim 1 , wherein the human subject exhibits a positive skin prick test to an allergen.

7. A method of treating one or more symptoms of seasonal allergic rhinitis in a human in need thereof comprising twice daily nasal administration to the human subject of about 1330 mcg per nostril of olopatadine hydrochloride and about 50 mcg per nostril of mometasone furoate, wherein (i) the olopatadine hydrochloride and mometasone furoate are administered in a single pharmaceutical composition as a nasal spray, (ii) the twice daily administration of the pharmaceutical composition provides a faster onset of action than twice daily administration of 1330 mcg per nostril of olopatadine hydrochloride alone, and (iii) the pharmaceutical composition comprises mometasone furoate in particulate form and olopatadine hydrochloride in dissolved form.

8. The method according to claim 7 , wherein the composition is administered twice daily for a period of 2 weeks.

9. The method according to claim 7 , wherein each administration of the composition is two sprays of the composition in each nostril, and each spray comprises about 25 mcg of mometasone furoate and about 665 mcg of olopatadine hydrochloride.

10. The method according to claim 7 , wherein the human subject exhibits a positive skin prick test to an allergen.

11. A method of reducing one or more symptoms associated with allergic rhinitis in a human subject in need thereof comprising twice daily nasal administration to the human subject of about 1330 mcg per nostril of olopatadine hydrochloride and about 50 mcg per nostril of mometasone furoate, wherein (i) the olopatadine hydrochloride and mometasone furoate are administered in a single pharmaceutical composition as a nasal spray, and (ii) the twice daily administration of the pharmaceutical composition provides a faster onset of action than twice daily administration of 1330 mcg per nostril of olopatadine hydrochloride alone.

12. The method according to claim 11 , wherein each administration of the composition is two sprays of the composition in each nostril, and each spray comprises about 25 mcg mometasone furoate and about 665 mcg olopatadine hydrochloride.

13. The method according to claim 11 , wherein the pharmaceutical composition is a suspension comprising mometasone furoate in particulate form and olopatadine in dissolved form.

14. The method according to claim 11 , wherein the allergic rhinitis is perennial allergic rhinitis.

15. The method according to claim 11 , wherein the allergic rhinitis is seasonal allergic rhinitis.

16. The method according to claim 11 , wherein the human subject exhibits a positive skin prick test to an allergen.

17. The method according to claim 11 , wherein the symptoms are selected from rhinorrhea, nasal congestion, nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of eyes, itching of ears or palate, coughing, ocular pruritus, excess lacrimation, headache, fatigue, malaise, and any combination of any of the foregoing.

18. A method of reducing eosinophil count in the nasal lavage of a human subject comprising twice daily nasal administration to the human subject of about 1330 mcg per nostril of olopatadine hydrochloride and about 50 mcg per nostril of mometasone furoate, wherein (i) the olopatadine hydrochloride and mometasone furoate are administered in a single pharmaceutical composition as a nasal spray, and (ii) the twice daily administration of the pharmaceutical composition provides a faster onset of action than twice daily administration of 1330 mcg per nostril of olopatadine hydrochloride alone.

19. A method of reducing total cell count in the nasal lavage of a human subject comprising twice daily nasal administration to the human subject of about 1330 mcg per nostril of olopatadine hydrochloride and about 50 mcg per nostril of mometasone furoate, wherein (i) the olopatadine hydrochloride and mometasone furoate are administered in a single pharmaceutical composition as a nasal spray, and (ii) the twice daily administration of the pharmaceutical composition provides a faster onset of action than twice daily administration of 1330 mcg per nostril of olopatadine hydrochloride alone.

20. The method of claim 1 , wherein the symptoms are nasal symptoms.

21. The method of claim 7 , wherein the symptoms are nasal symptoms.

22. The method of claim 11 , wherein the symptoms are nasal symptoms.

23. The method of claim 18 , wherein each administration of the composition is two sprays of the composition in each nostril, and each spray comprises about 25 mcg of mometasone furoate and about 665 mcg of olopatadine hydrochloride.

24. The method of claim 19 , wherein each administration of the composition is two sprays of the composition in each nostril, and each spray comprises about 25 mcg of mometasone furoate and about 665 mcg of olopatadine hydrochloride.

25. The method of claim 1 , wherein the subject is at least 12 years of age.

26. The method of claim 25 , wherein the allergic rhinitis is perennial allergic rhinitis.

27. The method of claim 25 , wherein the allergic rhinitis is seasonal allergic rhinitis.

28. The method of claim 27 , wherein each administration of the composition is two sprays of the composition in each nostril, and each spray comprises about 25 mcg of mometasone furoate and about 665 mcg of olopatadine hydrochloride.

29. The method of claim 11 , wherein the subject is at least 12 years of age.

30. The method of claim 29 , wherein the allergic rhinitis is perennial allergic rhinitis.

31. The method of claim 29 , wherein the allergic rhinitis is seasonal allergic rhinitis.

32. The method of claim 31 , wherein each administration of the composition is two sprays of the composition in each nostril, and each spray comprises about 25 mcg of mometasone furoate and about 665 mcg of olopatadine hydrochloride.

Assignments (3)
CHANGE OF ADDRESS Recorded Oct 26, 2023
From: GLENMARK SPECIALTY S.A.
To: GLENMARK SPECIALTY S.A.
Reel/Frame 065379/0694 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 28, 2015
From: GLENMARK PHARMACEUTICALS LTD.
To: GLENMARK SPECIALTY S.A.
Reel/Frame 037365/0650 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 22, 2015
From: KHAIRATKAR-JOSHI, NEELIMA; KULKARNI, ABHAY; WALE, DINESH PRADEEP; BHOSALE, VIKRAM M; AGARWAL, PIYUSH; KEOHANE, PATRICK; TANTRY, SUDEESH K; OH, CHAD
To: GLENMARK PHARMACEUTICALS LTD.
Reel/Frame 036007/0145 →
Priority Claims (1)
IN 3174/MUM/2013 · Oct 4, 2013 · national
Continuity (2)
Continuation In Part 14506122 · Oct 3, 2014
Related Publication 20150272966A1 · Oct 1, 2015