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Pharmaceutical compositions comprising FK506 derivatives and the ir use for the treatment of allergic diseases

A composition and technology for allergic conjunctivitis, applied in allergic diseases, drug combinations, medical preparations containing active ingredients, etc., can solve problems such as undetermined optimal dosage regimen for human patients

Inactive Publication Date: 2005-09-28
SUCAMPO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the optimal dosing regimen for the treatment of human patients has not yet been determined

Method used

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  • Pharmaceutical compositions comprising FK506 derivatives and the ir use for the treatment of allergic diseases
  • Pharmaceutical compositions comprising FK506 derivatives and the ir use for the treatment of allergic diseases
  • Pharmaceutical compositions comprising FK506 derivatives and the ir use for the treatment of allergic diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0094] Human patients with a history of allergy were divided into 5 groups, and one eye was treated with eye drops (placebo, 0.01% FK506, 0.03% FK506, 0.06% FK506 or 0.1% FK506) and the other was treated with placebo. Each eye drop was administered 4 times a day for 7 days, and 16 hours after the last instillation, the patient was administered eye drops containing the allergen at a concentration predetermined to cause a reaction in the patient. 100 patients with a baseline pruritus score of at least 3 were assessed on a scale of 0-4 with 4 being the most severe. Data on reduction in pruritus scores from baseline in figure 1 Indicated.

[0095] Such as figure 1 As shown, when all concentrations were statistically significant relative to placebo, there was a clear dose response, especially at 3 minutes post-challenge.

[0096] This application is based on application Ser. No. 60 / 402,051 filed in the United States, the contents of which are incorporated herein by reference.

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PUM

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Abstract

The invention provides ophthalmic compositions and methods treating the symptoms of ocular allergies. The principle active ingredient in these compositions and methods is macrolide compound, such as tacrolimus, ascomycin and rapamycin and their derivatives. Optimal concentrations and dosing regimens are provided.

Description

technical field [0001] The present invention relates to methods of treating ocular allergies. Background technique [0002] The incidence and prevalence of allergic conjunctivitis has increased dramatically over the past 40 years and today affects up to 20% of Americans. The condition can be seasonal if due to pollen from trees, grasses, or weeds, or perennial if the antigen is present in abundance throughout the year, such as animal dander; of the two, seasonal allergic conjunctival Inflammation is more common. Ophthalmologists believe that 80%-90% of all allergic conjunctivitis cases are seasonal, while the remaining 10%-20% are actually perennial. [0003] Eye allergies, such as allergic conjunctivitis, are currently available in the following categories: antihistamines, mast cell stabilizers, nonsteroidal anti-inflammatory drugs ("NSAIDS") and corticosteroids. Despite the availability of many products, none of which are completely satisfactory, there remains a need fo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07H15/04A61K9/00A61K31/436A61K31/4745A61K31/706A61K45/00A61K47/32A61P27/02A61P27/14A61P37/06
CPCA61K9/0048A61K31/436A61K31/4745A61P27/02A61P27/14A61P37/06A61P37/08
Inventor 上野隆司
Owner SUCAMPO PHARMA
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