Title:  Therapeutic method for reversing hyposmia in a human patient

United States Patent:  5,993,782

Appl. No.:  069490

Normal olfactory function restoration through topical application of an effective amount of fluticasone propionate to the olfactory epithelium. A patient should be started on 1 mg per day dosage and the dosage gradually inreased until the patient regains the sense of smell.

DETAILED DESCRIPTION OF THE INVENTION

Therepeutic Method for Reversing Steroid Dependent Asmosia

Return of sense of smell after several years loss and subsequent to polypectomies occurred in one patient over 60 years of age when only the oral steroid prednisone previously enabled successful restoration of normal olfactory function.

The hereinafter described therapeutic method for achieving restoration of the olfactory function has now been achieved without the use of systematic corticosteroid therapy and its many undesirable side effects.

Whether impairment of olfaction occurs because the olfactory cleft swells to stop air from reaching the olfactory epithelium or because inflammatory mediators alter the olfactory media and overlying mucous blanket is uncertain.

Administration of topical steroids in the form of a nasal spray such as FLONASE, a registered trademark of Glaxo Wellcome Inc. of Research Triangle Park, N.C. 22709 comprising an aerosol formulation of fluticasone propionate at normal daily doses of 200 mcg for nasal allergies did not restore olfaction. Product information of FLONASE indicates that maximum dosage for seasonal and year-round treatment of nasal allergies should not exceed 200 mcg/day and that there is no evidence that exceeding the recommended dose is more effective. U.S. Pat. No. 4,335,121 issued Jun. 15, 1992 incorporated herein by reference describes the method of manufacture of FLONASE describing therein important characteristics including the favorable ratio of topical anti-flammatory activity to undesired systemic activity of the formulated anti-inflammatory steroids of the androstane series. This important characteristic is especially highlighted in the Product Information publication for FLONASE which indicates under OVERDOSAGE that intranasal administration of 2 mg (10 times the recommended dose) of fluticasone propionate twice daily for 7 days to healthy human volunteers was well tolerated. The ability of the human patient to tolerate daily administration of 1 to 2 mg per day (5 to 10 times the recommended dose) led to the discovery of the present method for reversing hyposmia without the need for systemic corticosteroid thereby. A patient should be started on 1 mg per day dosage and the dosage gradually increased until the patient regains the sense of smell. Dosage of patients who have responded should then be reduced to a maintenance dosage sufficient to retain the patient's sense of smell thereby minimizing the possibility of systemic effects.

Claim 1 of 1 Claim

What is claimed is:

1. A therapeutic method for reversing hyposmia in a human patient in need thereof comprising administering to the olfactory epithelium of said patient a pharmaceutical aerosol composition comprising an effective amount of fluticasone propionate, wherein the effective amount is from 1 to 2 mg per day.

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