Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
1999-09-09
2001-10-02
Fay, Zohreh (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Cyclopentanohydrophenanthrene ring system doai
C514S169000
Reexamination Certificate
active
06297227
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to methods of treating sinusitis and otitis media (including otitis media with effusion and persistent middle ear effusion) involving the administration of a therapeutically effective amount of a corticosteroid. It specifically relates to such treatment involving the administration of a therapeutically effective amount of mometasone furoate. The subject matter of this patent application is related to that disclosed in pending U.S. patent applications, Ser. No. 09/391,795 filed of even date herewith, Ser. No. 08/376,506, filed Jan. 23, 1995, and Ser. No. 07/984,573, filed Apr. 29, 1998.
BACKGROUND OF THE INVENTION
Sinusitis is the most frequently reported chronic disease in the United States, affecting more than 14% of the population. Sinusitis is an inflammation of the mucosa of the paranasal sinuses. Generally, there is an allergic cause to sinusitis. Otitis media, like sinusitis, is also generally considered to have an allergic cause. These are also characterized by retention of thickened respiratory secretions; however, the inflammation is manifest in the ear rather than in the sinuses. A discussion of sinusitis and otitis media can be found in
Conn's Current Therapy
, 235 (1997);
Diseases of the Sinuses—A Comprehensive Textbook of Diagnosis and Treatment
, ed. M. E. Gershwin et al, Human Press, Totowa, N.J., pages 151-157 (1996); and
Allergy—Principles and Practice
, Volume II, ed. E. Middleton, Jr. et al, Mosby-Year Book, Inc., New York, pages 1027-1033 (1998). Also, a review of sinusitis and related facts is given by Z. Pelikan, “The Role of Allergy in Sinus Disease”,
Clinical Reviews in Allergy and Immunology
, 16, 55-156 (1998).
Sinusitis and otitis media are often typically treated as infectious diseases. The treatment typically includes administration of an antibiotic along with a corticosteroid and an antihistamine, or a nasal decongestant. such as described in, for example, J. Braun et al,
Allergy
, 52 (6) 650-655 (1997). There are, however, occasions, when the sinusitis or otitis media is not necessarily accompanied by an infection. This is particularly true when the disease is associated with allergic rhinitis. At those times, administration of an antibiotic may not be needed. Physicians, however, do not generally administer corticosteroids for these indications without accompanying antibiotic.
Certain corticosteroids, e.g., beclomethasone dipropionate, are commercially available for the treatment of diseases such as rhinitis and bronchial asthma. However, the art does not teach the utility of a corticosteroid as substantially a main component in the treatment of non-infective sinusitis or otitis media in the absence of antibiotics.
It would be desirable to find methods of treatment for non-infective sinusitis or otitis media using an effective amount of substantially a corticosteroid as an active ingredient in the absence of antibiotics.
It would also be desirable to find a corticosteroid which is therapeutically effective in treating sinusitis and otitis media and which also exhibits low bioavailability and low systemic side-effects when it is administered intra-nasally or by oral inhalation.
Other desires, objectives and advantages of the present invention will be apparent to those skilled in the art from the accompanying description and claims.
SUMMARY OF THE INVENTION
The above-noted objectives are addressed by the present invention which, in one embodiment, provides methods and pharmaceutical compositions for the treatment of non-infectious sinusitis and otitis media. The composition comprises a therapeutically effective amount of one or more corticosteroids or a pharmaceutically acceptable derivative of such corticosteroid(s). Additionally, a pharmaceutically acceptable carrier may be optionally present in the inventive composition. While still additional ingredient or ingredients may optionally be present, the corticosteroid(s) is (are) the major active ingredient(s) in the composition. Antibiotics, however, are absent in the composition. Preferred corticosteroids useful in the practice of the present invention are mometasone furoate (also known as SCH 32088) as well mometasone furoate monohydrate.
The present invention additionally discloses a method for the treatment of non-infectious sinusitis and otitis media or both in a mammalian organism in need of such treatment, such treatment comprising administering a pharmaceutical composition described above.
The present invention provides a method of treating non-infective sinusitis and otitis media or both in patients afflicted with that disease or diseases, which method comprises administering at least once-a-day to said patients a substantially non-systematically bio-available amount of a corticosteroid effective for treating said disease.
In an aspect of the present invention, there is provided a method of treating non-infective sinusitis and otitis media or both in patients afflicted with that disease or diseases which method comprises administering at least once-a-day to said patients an amount of a corticosteroid effective to maximize treating said sinusitis or otitis media while simultaneously substantially minimizing systemic absorption thereof.
In another aspect of the present invention, there is provided a method of treating non-infective sinusitis or otitis media or both in patients afflicted with said disease or diseases which method comprises administering at least once-a-day, via oral inhalation or nasal ingestion, to said patients an amount of a corticosteroid effective to maximize topically treating said disease while simultaneously substantially minimizing the systemic absorption thereof.
In yet another aspect of the present invention, there is provided a method of treating non-infective sinusitis or otitis media or both in patients afflicted with said disease(s) which method comprises administering at least once-a-day, via oral inhalation or nasal ingestion, to said patients an amount of mometasone furoate effective to maximize topically treating said disease while simultaneously substantially minimizing the systemic absorption thereof.
In a still another aspect of the present invention, there is provided a method of treating non-infective sinusitis or otitis media or both in patients afflicted with said disease(s) which method comprises administering at least once-a-day, via oral inhalation or nasal ingestion, to said patients an amount of mometasone furoate monohydrate effective to maximize topically treating said disease while simultaneously substantially minimizing the systemic absorption thereof.
REFERENCES:
patent: 4472393 (1984-09-01), Shapiro
patent: 4731477 (1988-03-01), Schumacher et al.
patent: 4873335 (1989-10-01), Schumacher et al.
Conn's Current Therapy,235 (1997).
Diseases of the Sinuses—A Comprehensive Textbook of Diagnosis and Treatment,ed. M. E. Gershwin et al, Human Press, Totowa, New Jersey (1996), pp. 151-157.
Allergy—Principles and Practice,vol. II, ed. E. Middleton, Jr. et al, Mosby-Year Book, Inc., New York (1998), pp. 1027-1033.
Z. Pelikan, “The Role of Allergy in Sinus Disease”,Clinical Reviews in Allergy and Immunology(1998) 16, 55-156.
J. Braun et al,Allergy(1997) 52 (6), 650-655.
Quercia et al,Hosp. Formul.,(1993) 28, 137-153.
Fay Zohreh
Schering Corporation
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