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 comprising:
 a) providing a liquid formulation comprising 50 mg. of diclofenac or a pharmaceutically acceptable salt thereof, 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; 
 ii) has been shown to achieve t max  in from about 10 to about 25 minutes; and 
   b) orally administering said formulation to a patient suffering from migraine associated with photophobia or phonophobia, and thereby treating said photophobia and phonophobia.   
     
     
         52 ) The method of  claim 51 , wherein said formulation comprises about 50 mg. of diclofenac potassium. 
     
     
         53 ) The method of  claim 51 , wherein said formulation has been shown to achieve t max  in from about 10 to about 20 minutes. 
     
     
         54 ) The method of  claim 51 , wherein said t max  has an inter-subject variability of less than about 70%. 
     
     
         55 ) The method of  claim 51 , wherein said formulation comprises a buffering agent. 
     
     
         56 ) The method of  claim 51 , wherein said migraine is defined as a disease manifested in a population of patients by periodic attacks of headache pain, nausea, photophobia and phonophobia, and said formulation has been shown to treat said periodic attacks of headache pain, nausea, photophobia and phonophobia. 
     
     
         57 ) A method of treating migraine headache pain for a 24-hour period in a human patient suffering from migraine headache pain comprising:
 a) providing a liquid formulation comprising about 50 mg. of diclofenac or a pharmaceutically acceptable salt thereof, 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; 
 ii) has been shown to achieve t max  in from about 10 to about 25 minutes; 
   b) orally administering said formulation to said patient, and thereby treating said migraine headache pain for 24 hours.   
     
     
         58 ) The method of  claim 57 , wherein said formulation comprises about 50 mg. of diclofenac potassium. 
     
     
         59 ) The method of  claim 57 , wherein said t max  has an inter-subject variability of less than about 70%. 
     
     
         60 ) The method of  claim 57 , wherein said formulation achieves t max  in from about 10 to about 20 minutes. 
     
     
         61 ) The method of  claim 57 , wherein said formulation comprises a buffering agent. 
     
     
         62 ) The method of  claim 57 , wherein said migraine is defined as a disease manifested in a population of patients by periodic attacks of headache pain, nausea, photophobia and phonophobia, and said formulation has been shown to treat said periodic attacks of headache pain, nausea, photophobia and phonophobia. 
     
     
         63 ) A method of treating migraine in a human patient comprising:
 a) providing a liquid formulation comprising 50 mg. of diclofenac or a pharmaceutically acceptable salt thereof, 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; 
 ii) has been shown to achieve t max  in from about 10 to about 25 minutes; 
 iii) said migraine is defined as a disease manifested in a population of patients by periodic attacks of headache pain, nausea, photophobia and phonophobia, and said formulation has been shown to treat said periodic attacks of headache pain, nausea, photophobia and phonophobia; and 
   b) orally administering said formulation to a patient suffering from migraine, and thereby treating said migraine.   
     
     
         64 ) The method of  claim 63 , wherein said formulation comprises about 50 mg. of diclofenac potassium. 
     
     
         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 63 , wherein said t max  has an inter-subject variability of less than about 70%. 
     
     
         67 ) The method of  claim 63 , wherein said formulation comprises a buffering agent.