US2017000771A1PendingUtilityA1

Thromboxane Receptor Antagonists in AERD/Asthma

Assignee: CUMBERLAND PHARMACEUTICALS INCPriority: Jun 30, 2015Filed: Jun 28, 2016Published: Jan 5, 2017
Est. expiryJun 30, 2035(~8.9 yrs left)· nominal 20-yr term from priority
Inventors:Leo Pavliv
A61P 43/00A61K 31/422A61P 11/00A61P 11/06A61K 31/616
55
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Claims

Abstract

The present invention is directed to methods of treating AERD (aspirin exacerbated respiratory disease) and/or asthma via the administration of a thromboxane receptor antagonist to a patient in need thereof.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of treating and/or preventing AERD or asthma in human patients, comprising administering to a human patient ifetroban or a pharmaceutically acceptable salt thereof in a daily dose from about 25 mg to about 400 mg. 
     
     
         2 . The method of  claim 1 , wherein the daily dose is sufficient to provide a plasma concentration of the thromboxane receptor antagonist of about 40 ng/ml to about 3,500 ng/ml. 
     
     
         3 . The method of  claim 1 , wherein the thromboxane A 2  antagonist is [1S-(1α,2α,3α,4α)]-2-[[3-[4-[(Pentylamino)carbonyl]-2-oxazolyl]-7-oxabicyclo[2.2.1]hept-2-yl]methyl]-benzenepropanoic acid, monosodium salt (ifetroban sodium). 
     
     
         4 . The method of  claim 3 , wherein the ifetroban sodium is administered orally and the dose is from about 150 mg/day to about 400 mg/day. 
     
     
         5 . The method of  claim 4 , wherein the dose is from about 200 mg/day to about 300 mg/day. 
     
     
         6 . The method of  claim 5 , wherein the dose is about 200 mg/day. 
     
     
         7 . A method of preventing, reversing or treating a symptom(s) of aspirin desensitization in AERD patients, comprising administering ifetroban or a pharmaceutically acceptable salt thereof to a human suffering from AERD in a daily dose from about 25 mg to about 400 mg. 
     
     
         8 . The method of  claim 7  wherein the ifetroban is administered orally and the dose is from about 150 mg/day to about 400 mg/day. 
     
     
         9 . The method of  claim 8 , wherein the ifetroban is ifetroban sodium and the dose is from about 200 mg/day to about 300 mg/day. 
     
     
         10 . The method of  claim 9 , wherein the ifetroban is ifetroban sodium and the dose is about 200 mg/day. 
     
     
         11 . The method of  claim 7 , wherein the daily dose of ifetroban treats a symptom associated with AERD or asthma including but not limited to nasal congestion (or stuffiness), eye watering, eye redness, coughing, wheezing, chest tightness; frontal headache, sensation of sinus pain, flushing, rash, hives, nausea, abdominal cramping, a general feeling of malaise, dizziness, difficulty breathing, and combinations of any of the foregoing. 
     
     
         12 . The method of  claim 7 , wherein the dose of ifetroban provides a plasma concentration of the thromboxane receptor antagonist of about 40 ng/ml to about 3,500 ng/ml, wherein the desired plasma concentration results in the patient experiencing a lessening of said symptom(s). 
     
     
         13 . A method of reducing rescue medications needed as a result of an aspirin-induced reaction in a human patient(s) suffering from AERD, comprising comprising administering ifetroban or a pharmaceutically acceptable salt thereof to the patient(s) in a daily dose from about 25 mg to about 400 mg. 
     
     
         14 . The method of  claim 13  wherein the ifetroban is administered orally and the dose is from about 150 mg/day to about 400 mg/day. 
     
     
         15 . The method of  claim 14 , wherein the ifetroban is ifetroban sodium and the dose is from about 200 mg/day to about 300 mg/day. 
     
     
         16 . The method of  claim 15 , wherein the ifetroban is ifetroban sodium and the dose is about 200 mg/day. 
     
     
         17 . The method of  claim 13 , wherein the daily dose of ifetroban treats a symptom associated with AERD or asthma including but not limited to nasal congestion (or stuffiness), eye watering, eye redness, coughing, wheezing, chest tightness; frontal headache, sensation of sinus pain, flushing, rash, hives, nausea, abdominal cramping, a general feeling of malaise, dizziness, difficulty breathing, and combinations of any of the foregoing. 
     
     
         18 . The method of  claim 17 , wherein the dose of ifetroban provides a plasma concentration of the thromboxane receptor antagonist of about 40 ng/ml to about 3,500 ng/ml, wherein the desired plasma concentration results in the patient experiencing a lessening of said symptom(s). 
     
     
         19 . The method of  claim 13 , wherein the daily dose is sufficient to provide a plasma concentration of the thromboxane receptor antagonist of about 40 ng/ml to about 3,500 ng/ml.

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