US2014128439A1PendingUtilityA1

Methods for Treating Gout Flares

61
Assignee: METABOLEX INCPriority: Nov 2, 2012Filed: Aug 7, 2013Published: May 8, 2014
Est. expiryNov 2, 2032(~6.3 yrs left)· nominal 20-yr term from priority
C07C 233/47C07C 59/68A61K 31/426A61K 31/192A61K 31/216
61
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Claims

Abstract

Methods of treating gout flares comprising administering a composition comprising a first urate-lowering agent are disclosed. In some aspects, the first urate-lowering agent is (−)-halofenate, (−)-halofenic acid, or a pharmaceutically acceptable salt thereof. Other aspects provide for methods of reducing the number, duration, frequency or intensity of gout flares experienced by a subject.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 - 18 . (canceled) 
     
     
         19 . A method for treating a gout flare experienced by a subject comprising administering to the subject a compound of Formula (I) 
       
         
           
           
               
               
           
         
         wherein R is selected from the group consisting of a hydroxy, lower alkanamido-lower alkoxy; and each X is independently a halogen; 
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         20 . The method of  claim 19 , wherein the compound or a pharmaceutically acceptable salt thereof is (−)-halofenate or (−)-halofenic acid, or a pharmaceutically acceptable salt thereof. 
     
     
         21 . The method of  claim 19 , wherein the compound is (−)-halofenate. 
     
     
         22 . A method for reducing the number, duration, frequency or intensity of gout flares experienced by a subject comprising administering a compound of Formula (I) of  claim 19  or a pharmaceutically acceptable salt thereof to the subject. 
     
     
         22 . The method of  claim 19 , wherein the compound is (−)-halofenate or (−)-halofenic acid, or a pharmaceutically acceptable salt thereof. 
     
     
         23 . The method of  claim 19 , wherein the compound is (−)-halofenate. 
     
     
         24 . A method for the treatment of hyperuricemia in a subject with gout comprising administering to a subject in need thereof a compound of Formula (I) of  claim 19  wherein the dose, frequency, and duration of administration are effective to reduce the number, duration, frequency, or intensity of gout flares experienced by the subject during the duration of the administration. 
     
     
         25 . The method of  claim 24 , wherein the compound or a pharmaceutically acceptable salt thereof is a compound of Formula (II) 
       
         
           
           
               
               
           
         
         wherein R 2  is lower alkanamido-lower alkyl; and each X is independently a halogen; and 
         each X is independently a halogen; or a pharmaceutically acceptable salt thereof. 
       
     
     
         26 . The method of  claim 24 , wherein the compound is (−)-halofenate or (−)-halofenic acid, or a pharmaceutically acceptable salt thereof. 
     
     
         27 . The method of  claim 24 , wherein the compound is (−)-halofenate. 
     
     
         28 . The method of  claim 24 , wherein the compound is (−)-halofenate and the compound is administered at from about 400 mg to about 1000 mg per day. 
     
     
         29 . The method of  claim 24 , wherein the duration of the administration is about 12 weeks. 
     
     
         30 . The method of  claim 24 , further comprising the administration of a second urate-lowering agent selected from the group consisting of a xanthine oxidase inhibitor, an inhibitor of uric acid production, a uricosuric agent and a uricase. 
     
     
         31 . The method of  claim 30 , wherein the second urate-lowering agent is selected from the group consisting of allopurinol, febuxostat, ulodesine, forodesine, oxypurinol, tisopurine, inositol, phytic acid, myo-inositiol, kaempferol, myricetin, quercetin, probenecid, 2-((5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-yl)thio)acetic acid, potassium 4-(2-((5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-yl)thio)acetamido)-3-chlorobenzoate, RDEA684, benzbromarone, sulfinpyrazone, amlodipine, atorvastatin, fenofibrate, levotofisopam, guaifenesin, losartan, adrenocorticotropic hormone and cortisone. 
     
     
         32 . The method of  claim 30 , wherein second urate-lowering agent is febuxostat. 
     
     
         33 . The method of  claim 30 , wherein the first urate-lowering agent is (−)-halofenate and is administered at from about 400 mg to about 800 mg per day, and the second urate-lowering agent is febuxostat and is administered at from about 40 mg to about 120 mg per day. 
     
     
         34 . A method of providing to a subject (−)-halofenic acid with an intraday peak-to-trough ratio of about 2.0 or less, comprising administering to the subject from about 100 mg to about 1000 mg per day of a compound of Formula (I) of  claim 19  or a pharmaceutically acceptable salt thereof.

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