Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2001-01-12
2001-07-17
Jarvis, William R. A. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S438000, C514S443000
Reexamination Certificate
active
06262077
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to compositions and methods for treating allergic rhinitis and other respiratory diseases. It specifically discloses compositions which comprise (i) combinations of antagonists of neurokinin receptors and antagonists of leukotriene receptors, and (ii) combinations of antagonists of neurokinin receptors and inhibitors of 5-lipoxygenase, as well as methods for treating the above-noted diseases using such compositions.
BACKGROUND OF THE INVENTION
Neurokinin (“NK”) receptors such as the NK
1
and the NK
2
receptors are found in the central nervous system and the circulatory system and the peripheral tissues of mammals, and are involved in a variety of biological processes. Antagonists of the neurokinin receptors are, therefore, expected to be useful in the treatment or prevention of various mammalian diseases such as, for example, pulmonary disorders such as asthma, cough, bronchospasm, chronic obstructive pulmonary diseases, and airway hyperactivity; skin disorders and itch, for example, atopic dermatitis, and cutaneous wheal and flare; neurogenic inflammatory diseases such as, arthritis, migraine, nociception; CNS diseases such as anxiety, emesis, Parkinson's disease, movement disorders and psychosis; convulsive disorders, renal disorders, urinary incontinence, ocular inflammation, inflammatory pain, and eating disorders such as food intake inhibition; allergic rhinitis, neurodegenerative disorders, psoriasis, Huntington's disease, depression and various disorders such as Crohn's disease. NK
1
receptors have been reported to be involved in microvascular leakage and mucus secretion, and NK
2
receptors have been associated with smooth muscle contraction, making NK
1
and NK
2
receptor antagonists especially useful in the treatment and prevention of asthma. NK
1
and NK
2
receptor antagonists have been reported such as, for example, in U.S. Pat. Nos. 5,798,359; 5,795,894; 5,789,422; 5,783,579; 5,719,156; 5,696,267; 5,691,362; 5,688,960; 5,654,316 (all assigned to Schering-Plough Corporation, Madison, N.J.); and in “Recent Advances in Neurokinin Receptor Antagonists”, by C. J. Ohnmacht Jr., et al,
Annual Reports in Medicinal Chemistry
, A. M. Doherty Ed., 33, 71-80 (1998).
The products of the 5-lipoxygenase (“5-LO”) pathway of arachidonic acid metabolism, particularly the leukotrienes, can mediate bronchoconstriction, mucous secretion, airway mucosal edema, chemotaxis and mobilization of cells into the airway in the inflammatory process of asthma. Therefore, inhibition of 5-LO should help cure, reduce or prevent such diseases. Similarly, leukotriene (“LK”) antagonists play a role in treating the multitude of symptoms associated with diseases of the respiratory tract, such as season allergic rhinitis, perennial allergic rhinitis, common colds, sinusitis and concomitant symptoms associated with allergic asthma. The symptoms of such diseases may include sneezing, itching runny nose, nasal congestion, redness of the eye, tearing, itching of the ears or palate, and coughs associated with postnasal drip. A discussion of leukotriene receptors may be found in R. Robertson,
Prostaglandins,
31, 395 (1986), and a discussion of leukotriene antagonists can be found in J. Musser et al,
Agents and Actions,
18, 332 (1986), J. Piwinski et al,
Annual Reports in Medicinal Chemistry,
22, 73-76 (1987), and R. Bell et al,
Annual Reports in Medicinal Chemistry,
32, 91 (1997).
It would be highly desirable to enhance the efficacy of the neurokinin antagonists to improve their overall efficacy, as well as to reduce or prevent the above-noted ailments by interfering with the activity of 5-LO and leukotriene receptors.
SUMMARY OF THE INVENTION
The afore-mentioned objective and other objectives and desires are addressed by the present invention which, in one embodiment, provides a composition for treating and preventing allergic rhinitis and other respiratory diseases such asthma, cough, wheezing and the like. The inventive composition comprises, in combination, a therapeutically effective amount of at least one neurokinin antagonist and a therapeutically effective amount of at least one leukotriene antagonist. One or more of the antagonists may be substituted by a pharmaceutically acceptable derivative such as salt, ester, and the like. Optionally, the composition may additionally contain a pharmaceutically acceptable carrier, a decongestant (such as, for example, pseudoephedrine), a cough suppressant (such as, for example, dexrtomethorphan), expectorant (such as, for example, guaifenesin), analgesics (such as, for example, aspirin, ibuprofen and acetaminophen) or mixtures thereof.
Generally, the amount of the neurokinin antagonist content in the inventive composition per unit dosage form is about 1-1,000 milligrams and that of the leukotriene antagonist is about 2-500 milligrams. Preferably, the respective amounts are about 10-500 milligrams and about 5-500 milligrams, and typically the respective amounts are about 50-200 milligrams and 10-50 milligrams.
The present invention additionally provides a composition for treating and preventing allergic rhinitis and other respiratory diseases such asthma, cough, wheezing and the like, the composition comprising, in combination, a therapeutically effective amount of at least one neurokinin antagonist and a therapeutically effective amount of at least one 5-LO inhibitor. One or more of the compounds may be substituted by a pharmaceutically acceptable derivative such as salt, ester, and the like. Additionally, the composition may contain a pharmaceutically acceptable carrier, a decongestant, a cough suppressant, and expectorant, or mixtures thereof.
The invention further provides methods for treating asthma, chronic obstructive pulmonary disease (“COPD”), and allergic disorders, sneezing, itching runny nose, nasal congestion, redness of the eye, tearing, itching of the ears or palate, sinusitis, and coughs associated with postnasal drip symptoms in a mammalian organism in need of such treatment comprising administering the pharmaceutical compositions described above.
REFERENCES:
patent: 6063926 (2000-05-01), Reichard et al.
patent: 9926924 (1999-06-01), None
Jarvis William R. A.
Kalyanaraman Palaiyur S.
Kim Vickie
Schering Corporation
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