Diclofenac formulations and methods of use

Abstract

Methods and formulations are provided for treating migraine and other acute pain episodes using diclofenac, and formulations of diclofenac that provide both rapid and sustained relief from acute pain. Methods and formulations are also provided for treating symptoms that often accompany migraine and acute pain such as photophobia, phonophobia, nausea and vomiting.

1 - 50 ) (canceled) 
     
     
         51 ) A method of treating migraine associated with phonophobia or photophobia in a human patient in need thereof comprising: a) providing a liquid formulation comprising 50 mg. of diclofenac potassium, wherein said formulation: i) is provided as a powder formulation and dissolved or suspended in water immediately before administration, or as a liquid formulation that is ingested with or without further mixing; and ii) has been shown to achieve t max  in from about 10 to about 25 minutes; and b) orally administering said formulation to said patient suffering from migraine associated with photophobia or phonophobia, wherein said formulation treats said photophobia or phonophobia. 
     
     
         52 ) The method of  claim 51 , wherein said method is for treating migraine associated with phonophobia and photophobia, said formulation is administered to a patient suffering from migraine associated with photophobia and phonophobia, and said formulation treats said photophobia and phonophobia. 
     
     
         53 ) The method of  claim 51 , wherein said formulation is provided as a powder formulation and dissolved or suspended in water immediately before administration. 
     
     
         54 ) The method of  claim 52 , wherein said formulation is provided as a powder formulation and dissolved or suspended in water immediately before administration. 
     
     
         55 ) The method of  claim 51  wherein said formulation has been shown to achieve t max  in from about 10 to about 20 minutes. 
     
     
         56 ) The method of  claim 52  wherein said formulation has been shown to achieve t max  in from about 10 to about 20 minutes. 
     
     
         57 ) The method of  claim 53  wherein said formulation has been shown to achieve t max  in from about 10 to about 20 minutes. 
     
     
         58 ) The method of  claim 54  wherein said formulation has been shown to achieve t max  in from about 10 to about 20 minutes. 
     
     
         59 ) The method of  claim 55  wherein said formulation has been shown to achieve a C max  of from about 1400 to about 2500 ng/ml. 
     
     
         60 ) The method of  claim 56  wherein said formulation has been shown to achieve a C max  of from about 1400 to about 2500 ng/ml. 
     
     
         61 ) The method of  claim 57  wherein said formulation has been shown to achieve a C max  of from about 1400 to about 2500 ng/ml. 
     
     
         62 ) The method of  claim 58  wherein said formulation has been shown to achieve a C max  of from about 1400 to about 2500 ng/ml. 
     
     
         63 ) A method of treating 24-hour recurrent migraine in a human patient in need thereof suffering from migraine comprising: a) providing a liquid formulation comprising 50 mg. of diclofenac potassium, wherein said formulation: i) is provided as a powder formulation and dissolved or suspended in water immediately before administration, or as a liquid formulation that is ingested with or without further mixing; and ii) has been shown to achieve t max  in from about 10 to about 25 minutes; and b) orally administering said formulation to said patient requiring treatment of recurrent migraine, wherein said administration treats said recurrent migraine. 
     
     
         64 ) The method of  claim 63 , wherein said formulation is provided as a powder formulation and dissolved or suspended in water immediately before administration. 
     
     
         65 ) The method of  claim 63  wherein said formulation has been shown to achieve t max  in from about 10 to about 20 minutes. 
     
     
         66 ) The method of  claim 64  wherein said formulation has been shown to achieve t max  in from about 10 to about 20 minutes. 
     
     
         67 ) The method of  claim 65  wherein said formulation has been shown to achieve a C max  of from about 1400 to about 2500 ng/ml. 
     
     
         68 ) The method of  claim 66  wherein said formulation has been shown to achieve a C max  of from about 1400 to about 2500 ng/ml. 
     
     
         69 ) A method of treating migraine in a human patient in need thereof comprising: a) providing a liquid formulation comprising 50 mg. of diclofenac potassium, wherein said formulation: i) is provided as a powder formulation and dissolved or suspended in water immediately before administration, or as a liquid formulation that is ingested with or without further mixing; and ii) has been shown to achieve t max  in from about 10 to about 20 minutes; and b) orally administering said formulation to a patient suffering from migraine, wherein said migraine is defined as a disease manifested in a population of patients by periodic attacks of headache pain, nausea, photophobia and phonophobia. 
     
     
         70 ) The method of  claim 69 , wherein said formulation is provided as a powder formulation and dissolved or suspended in water immediately before administration.