Claims for Patent: 9,511,054

Summary for Patent: 9,511,054

Title:	Histamine balance restoration methods
Abstract:	Several embodiments provided herein relate to histamine dosing regimens are and uses of such regimens in the restoration of histamine balance in subjects suffering from, for example, histapenia and/or histadelia. Several embodiments also relate to the use of histamine dosing regimens for the treatment and/or prevention of migraine headaches.
Inventor(s):	Arnou; Cristian (Santa Monica, CA)
Assignee:	BioHealthonomics Inc. (Santa Monica, CA)
Application Number:	14/684,174
Patent Claims:	1. A method for restoring histamine balance in a subject through the administration of a histamine receptor activator composition, comprising: administering to the subject a first administration of a first dose of a histamine receptor activator composition, wherein the histamine receptor activator comprises a histamine salt selected from the group consisting of histamine diphosphate, histamine phosphate, and histamine dihydrochloride; administering to the subject a first administration of a second dose of the histamine receptor activator composition, wherein the first administration of the first and second doses are separated by a first time interval, wherein the second dose of the first administration has a concentration of said histamine receptor activator composition that is greater than the concentration of the first dose of said histamine receptor activator composition and an administered volume that is the same as an administered volume of the first dose; administering to said subject a second administration of the first dose of the histamine receptor activator composition; and administering to said subject a second administration of the second dose of the histamine receptor activator composition, wherein the second administration of the first and second doses are separated by a second time interval, wherein the second dose of the second administration has a concentration of said histamine receptor activator composition that is greater than the concentration of the first dose of said histamine receptor activator composition and an administered volume that is the same as an administered volume of the first dose; and wherein the repeated administration of the first and second doses of the histamine receptor activator composition normalizes an activity of one or more histamine receptors of the subject, thereby restoring histamine balance. 2. The method of claim 1, further comprising at least a third administration of the first dose of the histamine receptor activator composition and at least a third administration of the second dose of the histamine receptor activator composition. 3. The method of claim 1, wherein the restoration of histamine balance treats one or more of histadelia, histapenia, migraine headaches, Parkinson's Disease, Alzheimer's Disease, amyotrophic lateral sclerosis and epilepsy. 4. The method of claim 1, wherein the first dose of the histamine receptor activator composition is administered subcutaneously at a concentration configured to activate one or more of a histamine H3 receptor and a histamine H4 receptor, and wherein the second dose of the histamine receptor activator composition is administered subcutaneously at a concentration configured to activate one or more of a histamine H1 receptor and a histamine H2 receptor. 5. The method of claim 1, wherein the administering comprises administration via a route selected from the group consisting of subcutaneous injection, intravenous injection, intraarterial injection, intramuscular injection, oral delivery, transdermal delivery, sublingual delivery, infusion, suppository, and inhalation delivery. 6. The method of claim 1, wherein said subject is susceptible to migraine headaches as a result of histamine imbalance and the restored histamine balance leads to a reduction in frequency and/or intensity of migraine headaches. 7. The method of claim 1, wherein the first time interval is equal to the second time interval. 8. The method of claim 1, wherein the first dose of said histamine receptor activator composition has a concentration of histamine receptor activator ranging from between about 0.1 ng/mL to about 10 ng/mL, wherein the second dose of the histamine receptor activator composition has a concentration of histamine receptor activator ranging from between about 0.35 .mu.g/mL to about 10 .mu.g/mL. 9. The method of claim 1, wherein the first time interval results in an administration frequency of between one and three times per week. 10. The method of claim 1, further comprising administering an additional agonist of any of the histamine H1, H2, H3, or H4 receptors. 11. The method of claim 1, wherein the first time interval is 2 to 4 days. 12. The method of claim 1, wherein the second time interval is 5 to 8 days. 13. The method of claim 2, wherein the third time interval is 12 to 16 days. 14. The method of claim 1, wherein the first and second doses comprise a subcutaneous injection of 0.01 to 0.1 mL histamine receptor activator composition. 15. The method of claim 14, wherein the first and second doses comprise a subcutaneous injection of 0.01 to 0.05 mL histamine receptor activator composition. 16. The method of claim 14, wherein the first and second doses comprise a subcutaneous injection of 0.05 mL histamine receptor activator composition. 17. The method of claim 1, wherein the first dose of histamine receptor activator composition is configured to activate a histamine H3 receptor and a histamine H4 receptor. 18. The method of claim 1, wherein the second dose of histamine receptor activator composition is configured to activate a histamine H1 receptor and a histamine H2 receptor.

Details for Patent 9,511,054

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Alk-abello, Inc.	HISTATROL	positive skin test control-histamine	Injection	103754	09/29/1950		2032-12-05
Jubilant Hollisterstier Llc	N/A	positive skin test control-histamine	Injection	103891	03/13/1924		2032-12-05