METHOD AND COMPOSITION FOR TREATING MIGRAINES
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.
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.