Method and composition for treating migraines

Abstract

A method for treating migraines is disclosed. The method utilizes a rapid drug delivery system which prevents deactivation or degradation of the active agent, including small molecules and peptides being administered to a patient in need of treatment. In particular, the drug delivery system is designed for inhalation for delivery of drugs to the pulmonary circulation in a rapid and therapeutically effective manner.

We claim: 
     
         1 . A method of treating symptoms associated with migraine comprising:
 administering to a subject in need of treatment for migraine symptoms a dry powder pharmaceutical composition comprising an effective amount of a serotonin receptor agonist and a diketopiperazine or a salt thereof.   
     
     
         2 . The method of  claim 1 , wherein the dry powder pharmaceutical composition is administered by inhalation. 
     
     
         3 . The method of  claim 1 , wherein said diketopiperazine is 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine; wherein X is selected from the group consisting of succinyl, glutaryl, maleyl, and fumaryl; or a pharmaceutically acceptable salt thereof. 
     
     
         4 . The method of  claim 1 , wherein the dry powder pharmaceutical composition is manufactured as a unit dose for oral inhalation. 
     
     
         5 . The method of  claim 4 , wherein said inhalable dry powder pharmaceutical composition further comprises a pharmaceutically acceptable carrier or excipient. 
     
     
         6 . The method of  claim 4 , wherein the dry powder formulation is administered to said subject by pulmonary inhalation using a breath powered, dry powder inhalation system. 
     
     
         7 . The method of  claim 1 , wherein the serotonin receptor agonist is for treating moderate to severe head pain associated with the migraine. 
     
     
         8 . The method of  claim 1 , wherein the serotonin receptor agonist is a triptan. 
     
     
         9 . The method of  claim 8 , wherein the triptan is selected from the group consisting of sumatriptan, almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan and pharmaceutically acceptable salts thereof, 
     
     
         10 . The method of  claim 8 , wherein the triptan is sumatriptan succinate. 
     
     
         11 . The method of  claim 8 , wherein the triptan is rizatriptan benzoate. 
     
     
         12 . The method of  claim 1 , wherein the dry powder pharmaceutical composition further comprises an aliphatic amino acid. 
     
     
         13 . The method of  claim 12 , wherein the aliphatic amino acid is selected from the group consisting of alanine, glycine, leucine, isoleucine, norleucine, and serine. 
     
     
         14 . The method of  claim 12 , wherein the aliphatic amino acid is about 0.5% to about 30% by weight of the composition. 
     
     
         15 . The method of  claim 1 , wherein the dry powder pharmaceutical composition further comprises L-leucine. 
     
     
         16 . The method of  claim 1 , wherein the dry powder pharmaceutical composition further comprises an active agent. 
     
     
         17 . The method of  claim 1 , wherein the diketopiperazine is bis-3,6[(N-fumaryl-4-aminobutyl]-2,5-diketopiperazine or a salt thereof. 
     
     
         18 . The method of  claim 17 , wherein the diketopiperazine is bis-3,6-[(N-fumaryl-4-aminobutyl)]-2,5-diketopiperazine disodium salt. 
     
     
         19 . The method of  claim 6 , wherein the breath powered, dry powder inhalation system comprises a cartridge containing said dry powder pharmaceutical composition. 
     
     
         20 . The method of  claim 16 , wherein the active agent is a vasoconstrictor.