US2022211674A1PendingUtilityA1

Thromboxane Receptor Antagonists in AERD/Asthma

76
Assignee: CUMBERLAND PHARMACEUTICALS INCPriority: Jun 30, 2015Filed: Mar 28, 2022Published: Jul 7, 2022
Est. expiryJun 30, 2035(~9 yrs left)· nominal 20-yr term from priority
Inventors:Leo Pavliv
A61P 11/06A61K 31/422A61P 11/00A61P 43/00A61K 31/616
76
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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
1 - 19 . (canceled) 
     
     
         20 . A method for treating and/or preventing AERD in a human patient, comprising administering ifetroban or a pharmaceutically acceptable salt thereof to the patient in a daily dose of about 200 mg, wherein the composition is administered orally. 
     
     
         21 . The method of  claim 20 , wherein the daily dose is sufficient to provide a plasma concentration of the ifetroban or pharmaceutically acceptable salt thereof of about 1 ng/ml to about 1,000 ng/ml. 
     
     
         22 . The method of  claim 20 , wherein the ifetroban or pharmaceutically acceptable salt thereof is [1S-(1α,2α,3α,4α)]-24[344-[(Pentylamino)carbonyl]-2-oxazolyl]-7-oxabicyclo[2.2.1]hept-2-yl]methyl]-benzenepropanoic acid, monosodium salt (ifetroban sodium). 
     
     
         23 . A method of preventing, reversing or treating a symptom(s) of aspirin desensitization in a AERD patient, comprising administering ifetroban or a pharmaceutically acceptable salt thereof to the patient in a daily dose of about 200 mg, wherein the composition is administered orally. 
     
     
         24 . The method of  claim 23 , wherein the ifetroban is ifetroban sodium. 
     
     
         25 . The method of  claim 23 , wherein the daily dose of ifetroban treats a symptom selected from the group consisting of nasal polyps, 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. 
     
     
         26 . The method of  claim 23 , 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). 
     
     
         27 . A method for reducing rescue medications needed as a result of an aspirin-induced reaction in a human patient suffering from AERD, comprising administering ifetroban or a pharmaceutically acceptable salt thereof to the patient in a daily dose of about 200 mg, wherein the composition is administered orally. 
     
     
         28 . The method of  claim 27 , wherein the ifetroban is ifetroban sodium. 
     
     
         29 . The method of  claim 27 , wherein the daily dose of ifetroban treats a symptom associated with AERD selected from the group consisting of nasal polyps, 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. 
     
     
         30 . The method of  claim 29 , 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). 
     
     
         31 . The method of  claim 27 , 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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