Claims for Patent: 8,420,106

Summary for Patent: 8,420,106

Title:	Extramuscular treatment of traumatic-induced migraine headache
Abstract:	A method for selection and treatment of externally caused migraine headache, the method includes identifying a patient group having chronic migraine headache; determining the identified patient group, a specific patient with a post traumatic migraine headache; and administering to the selected patient by injection of a therapeutically effective amount of a Botulinum neurotoxin in a pharmaceutically safe form to the selected patient\'s head or upper neck; administration preferably being on the sites of the trigeminal cervical system, enabling axonal transport of the neurotoxin from distal to central sites; and the administration preferably comprising extramuscular injection of the neurotoxin of suitable dilution (a) over the aponeurotic fascia, or (b) intra-orally, in a foramina of the sphenopalatine ganglion, or (c) to emerging exit points of nerves including foraminal sites.
Inventor(s):	Binder; William J. (Beverly Hills, CA)
Assignee:
Application Number:	13/478,828
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,420,106
Patent Claims:	1. A method for selection and treatment of externally caused migraine headache, said method comprising: identifying a patient group having migraine headache; of the identified patient group, determining a specific patient with a post traumatic migraine headache; and administering a therapeutically effective amount of a suitably diluted Botulinum toxin in a pharmaceutically safe form to the selected patient's head to reduce headaches, wherein the administration comprises the extra muscular injection of the Botulinum Toxin. 2. The method according to claim 1 wherein the externally caused migraine headache is post-traumatic stress disorder (PTSD). 3. The method according to claim 1 wherein the externally caused migraine headache is traumatic brain injury (TBI). 4. The method according to claim 1 wherein the Botulinum toxin is Botulinum toxin A. 5. The method according to claim 4 wherein the Botulinum toxin A is onabotulinumtoxinA. 6. The method according to claim 1 wherein the Botulinum toxin is Botulinum Toxin B. 7. The method according to claim 1 wherein the Botulinum toxin is an Endotoxin. 8. The method of claim 7 wherein the Endotoxin is an endopeptidase. 9. A method for selection and treatment of externally caused migraine headache, said method comprising: identifying a patient group having chronic migraine headache; of the identified patient group, determining a specific patient with a post traumatic migraine headache; and administering to the selected patient by injection of a therapeutically effective amount of a Botulinum toxin in a pharmaceutically safe form to the selected patient's head or upper neck to reduce headaches; administration being on the sites of the trigeminal cervical system, enabling axonal transport of the Botulinum toxin from distal to central sites; and the administration comprising extramuscular injection of the Botulinum toxin of suitable dilution (a) over the aponeurotic fascia to enable the Botulinum toxin to diffuse into distal sensory nerves, in order to concentrate the Botulinum toxin over the occipital-parietal-frontal head region, or (b) intra-orally, in a foramina of the sphenopalatine ganglion for enabling diffusion of the Botulinum toxin to the ganglion, or (c) to emerging exit points of nerves including foraminal sites for enabling the Botulinum toxin access to concentrated nerve bundles at exit points of the foramina. 10. The method according to claim 9 wherein the Botulinum toxin is Botulinum toxin A. 11. The method according to claim 10 wherein the Botulinum toxin A is onabotulinumtoxinA. 12. The method according to claim 9 wherein the administration to the aponeurotic fascia includes dilution of about 4-10 cc of normal saline per 100 units of Botulinum toxin. 13. The method according to claim 9 wherein the administrations according to (b) and (c) are at a dilution of about 1 cc normal saline per 100 units of Botulinum toxin. 14. The method according to claim 9 wherein the Botulinum toxin is an Endotoxin. 15. The method according to claim 14 wherein the Endotoxin is an endopeptidase. 16. The method according to claim 9 wherein the Botulinum toxin is Botulinum toxin B. 17. The method according to claim 9 wherein the externally caused migraine headache is post-traumatic stress disorder (PTSD). 18. The method according to claim 9 wherein the externally caused migraine headache is traumatic brain injury (TBI).

Details for Patent 8,420,106

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Allergan, Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	12/09/1991		2032-03-12
Allergan, Inc.	BOTOX	onabotulinumtoxina	For Injection	103000	12/09/1991		2032-03-12