Search

EP-2922553-B1 - TREATMENT OF ALLERGIC RHINITIS USING A COMBINATION OF MOMETASONE AND OLOPATADINE

EP2922553B1EP 2922553 B1EP2922553 B1EP 2922553B1EP-2922553-B1

Inventors

  • KHAIRATKAR JOSHI, NEELIMA
  • KULKARNI, ABHAY
  • WALE, Dinesh Pradeep
  • BHOSALE, Vikram Mansingh
  • AGARWAL, PIYUSH
  • KEOHANE, PATRICK
  • TANTRY, Sudeesh K.
  • OH, Chad

Dates

Publication Date
20260506
Application Date
20141003

Claims (8)

  1. A fixed-dose pharmaceutical suspension comprising mometasone furoate in particulate form and olopatadine hydrochloride in dissolved form for use in treating allergic rhinitis in a human in need thereof, wherein (i) the suspension is nasally administered as 2 sprays per nostril of the human twice daily, and (ii) each spray comprises 25 µg of mometasone furoate and 665 µg of olopatadine hydrochloride.
  2. The suspension for use according to claim 1, wherein the suspension is administered for a period of at least 1 week.
  3. The suspension for use according to any one of claims 1-2, wherein the suspension is administered for a period of at least 2 weeks.
  4. The suspension for use according to any one of claims 1-3, wherein the allergic rhinitis is seasonal allergic rhinitis or perennial allergic rhinitis, and/or nasal symptoms associated therewith.
  5. The suspension for use according to claim 4, wherein the nasal symptoms associated with seasonal allergic rhinitis or perennial allergic rhinitis is selected from sneezing, nasal itching, rhinorrhea, and nasal congestion.
  6. The suspension for use according to claim 5, wherein the nasal symptom associated with seasonal allergic rhinitis or perennial allergic rhinitis is selected from sneezing and nasal congestion.
  7. The suspension for use according to any one of claims 1-6, wherein the human exhibits a positive skin prick test to an allergen.
  8. The suspension for use according to any one of claims 1-7, wherein the human is at least 12 years of age.

Description

TECHNICAL FIELD OF THE INVENTION The present patent application relates to a fixed-dose pharmaceutical suspension comprising mometasone furoate in particulate form and olopatadine hydrochloride in dissolved form for use in treating allergic rhinitis in a human in need thereof; wherein (i) the suspension is nasally administered as 2 sprays per nostril of the human twice daily, and (ii) each spray comprises 25 µg of mometasone furoate and 665 µg of olopatadine hydrochloride. BACKGROUND OF THE INVENTION Allergic rhinitis is a medical term for inflammation and irritation of the mucous membrane inside the nose. It generally occurs when an allergen such as pollen, dust, or animal dander (particles of shed skin and hair) is inhaled by an individual with a sensitized immune system. Allergic rhinitis may cause additional symptoms such as rhinorrhea (excess nasal secretion), sneezing, nasal itching, nasal congestion and obstruction, coughing, headache, fatigue and malaise. Symptoms may vary in severity between individuals. Many treatment options are available for treating allergic rhinitis such as, for example, antihistamines (e.g., cetirizine and loratadine), steroids (e.g., triamcinolone), decongestants, and leukotriene receptor antagonists (e.g., montelukast). These treatments are generally administered orally or nasally. Olopatadine hydrochloride, an antihistamine, is chemically described as (Z)-11-[3-(dimethylamino) propylidene]-6, 11-dihydrodibenz [b, e] oxepin-2-acetic acid hydrochloride, and is disclosed in U.S. Patent Nos. 4,871,865 and 4,923,892. It is commercially available in the United States as PATANASE® Nasal Spray, which contains 0.6% w/v olopatadine (base) in a non-sterile aqueous solution. It is indicated for the relief of the symptoms of seasonal allergic rhinitis (SAR) in adults and children 6 years of age and older. Mometasone furoate is a glucocorticosteroid used topically to reduce inflammation of the skin or in the airways. Mometasone furoate monohydrate is commercially available in the United States as NASONEX®, a nasal spray indicated for (i) the treatment of nasal symptoms of allergic rhinitis in patients ≥2 years of age, (ii) the treatment of nasal congestion associated with seasonal allergic rhinitis in patients ≥2 years of age, (iii) the prophylaxis of seasonal allergic rhinitis in patients ≥12 years of age, and (iv) the treatment of nasal polyps in patients ≥18 years of age. It is available as 50 mcg in a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate equivalent to 0.05% w/w mometasone furoate (calculated on the anhydrous basis). International Publication No. WO 2011/141929 discloses an aqueous nasal spray solution comprising fluticasone and olopatadine. U.S. Patent No. 6,127,353 discloses a pharmaceutical composition of mometasone furoate monohydrate. U.S. Patent Nos. 7,977,376 and 8,399,508 disclose a topical formulation of olopatadine hydrochloride. International Publication No. WO 2011/008923 discloses a nasal spray regimen of olopatadine for children. International Publication No. WO 1995/020393 discloses the use of mometasone furoate for treating airway passage and lung diseases. International Publication No. WO 2010/025236 discloses a combination of a nasal steroid and a nasal antihistamine for the treatment of viral upper respiratory tract infections, upper respiratory infections, and common colds. WO2009/003199A1 is directed to methods of treating nasal and/or ophthalmic diseases, symptoms, or disorders that are therapeutically responsive to corticosteroid therapy by delivering aqueous solution formulations comprising a corticosteroid, SAE-CD and a pharmaceutically acceptable aqueous liquid carrier to nasal and ophthalmic tissues. There still exists a need for easy to use and effective treatments for allergic rhinitis. SUMMARY OF THE INVENTION The invention is set out in the appended set of claims. The present invention relates to a fixed dose combination of mometasone furoate in particulate form and olopatadine hydrochloride in dissolved form and its use for the treatment of rhinitis in a subject in need thereof. The inventors have surprisingly found that mometasone furoate and olopatadine hydrochloride act synergistically in the treatment of allergic rhinitis and is more effective and provides better therapeutic value than treatment with either active ingredient alone. In an aspect, the present invention relates to a fixed-dose pharmaceutical suspension comprising mometasone furoate in particulate form and olopatadine hydrochloride in dissolved form for use in treating allergic rhinitis in a human in need thereof comprising nasally administering to the subject an effective amount of a fixed-dose pharmaceutical composition comprising mometasone furoate in particulate form and olopatadine hydrochloride in dissolved form; wherein(i) the suspension is nasally administered as 2 sprays per nostril of the human twice daily; an