Topical therapy for migraine

Abstract

The invention is directed to formulations and methods of treating a migraine and/or cluster headache with a serotonin agonist, pharmaceutically acceptable salt thereof, or derivative thereof.

1 . (canceled) 
     
     
         2 . A method for treating a migraine or cluster headache comprising:
 applying a topical formulation containing an effective amount of a topically effective triptan to the skin at the posterior cervical area of a human patient in close proximity to the brain stem to provide relief of a migraine or cluster headache which is occurring or is imminent in the patient.   
     
     
         3 . The method of  claim 2 , further comprising preparing the topical formulation as a preparation selected from the group consisting of cream, gel, ointment, paste, lotion, emulsion, viscous liquid, foam, and a semisolid. 
     
     
         4 . The method of  claim 3 , further comprising preparing the topical formulation in an aqueous based vehicle. 
     
     
         5 . The method of  claim 4 , wherein the triptan is in a topical formulation selected from the group consisting of an cream, ointment, gel and lotion. 
     
     
         6 . The method of  claim 2 , wherein the patient experiences relief of the migraine or cluster headache within about 2 hours after applying the topical formulation. 
     
     
         7 . The method of  claim 2 , wherein the triptan is naratriptan. 
     
     
         8 . The method of  claim 2 , wherein the triptan is sumatriptan or a pharmaceutically acceptable salt thereof. 
     
     
         9 . The method of  claim 2 , wherein the triptan is selected from the group consisting of sumatriptan, sumatriptan succinate, and mixtures thereof. 
     
     
         10 . The method of  claim 2 , wherein the triptan is zolmitriptan or a pharmaceutically acceptable salt thereof. 
     
     
         11 . The method of  claim 2 , wherein the triptan is rizatriptan or a pharmaceutically acceptable salt thereof. 
     
     
         12 . The method of  claim 2 , wherein the triptan is almotriptan or a pharmaceutically acceptable salt thereof. 
     
     
         13 . The method of  claim 2 , wherein the triptan is frovatriptan or a pharmaceutically acceptable salt thereof. 
     
     
         14 . The method of  claim 2 , wherein the triptan is eletriptan or a pharmaceutically acceptable salt thereof. 
     
     
         15 . The method of  claim 2 , further comprising applying a second application of said triptan to the same or different headache region within about 2 hours after applying the first application. 
     
     
         16 . The method of  claim 2 , further comprising applying the formulation to an area of intact skin in the range of about 20 cm 3  to about 60 cm 3 . 
     
     
         17 . The method of  claim 2 , further comprising reducing the side effects of the triptan as compared to oral administration of the triptan by applying the formulation to the posterior cervical area. 
     
     
         18 . A method for treating a migraine or cluster headache comprising:
 applying a dose of a pharmaceutical formulation comprising from about 0.5 to about 200 mg of a topically effective triptan topically to the skin at the posterior cervical area of a human patient in close proximity to the brain stem, to provide relief of a migraine or cluster headache which is occurring or is imminent in said patient to provide relief from a migraine or cluster headache within about 2 hours after topical administration to the human patient.   
     
     
         19 . The method of  claim 14 , wherein the triptan is in a topical formulation selected from the group consisting of a cream, ointment, gel, lotion, paste, emulsion, viscous liquid, foam, and a semisolid. 
     
     
         20 . The method of  claim 15 , wherein the triptan is selected from the group consisting of sumatriptan, naratriptan, eletriptan, rizatriptan, zolmitriptan, almotriptan, frovatriptan, and pharmaceutically acceptable salts thereof. 
     
     
         21 . The method of  claim 14 , further comprising reducing the side effects of the indole serotonin agonist as compared to oral administration of the indole serotonin agonist by applying the formulation to the posterior cervical area. 
     
     
         22 . The method of  claim 14 , further comprising providing the dose of the indole serotonin agonist in a metered dose device containing multiple unit doses of said indole serotonin agonist. 
     
     
         23 . The method of  claim 14 , wherein the patient experiences pain relief within less than about 30 minutes after application of the dose. 
     
     
         24 . A method for treating a migraine or cluster headache comprising:
 topically applying a dose of a topical aqueous based immediate release formulation containing from about 0.5 to about 200 mg of sumatriptan or a pharmaceutically acceptable salt thereof, by weight based on the succinate salt of sumatriptan, to the skin at the posterior cervical area of a human patient in close proximity to the brain stem, to deliver the sumatriptan at the posterior cervical area of the human patient such that the dose provides relief from a migraine or cluster headache within about 2 hours after topical administration to the human patient.