Claims for Patent: 8,501,195

Summary for Patent: 8,501,195

Title:	Injection paradigm for administration of botulinum toxins
Abstract:	Disorders such as headaches can be treated by administration of a botulinum toxin to a patient suffering therefrom, such as a migraine headache. A combined a fixed site/fixed dose and an optional follow the pain variable dosage and injection site paradigm is disclosed for optimizing clinical effectiveness of botulinum toxin administration for patients suffering headache, particularly chronic migraine.
Inventor(s):	Turkel; Catherine C. (Newport Coast, CA), Brin; Mitchell F. (Newport Beach, CA), Aurora; Sheena K. (Seattle, WA), Dodick; David W. (Scottsdale, AZ)
Assignee:	Allergan, Inc. (Irvine, CA)
Application Number:	13/075,485
Patent Claims:	1. A method for treating or reducing the occurrence of a headache in a patient with chronic migraine headaches, the method consisting of: local administration of a botulinum neurotoxin to the frontalis, corrugator, procereus, occipitalis, temporalis, trapezius and cervical paraspinal muscles of the patient that suffers from the migraine headache; wherein the botulinum neurotoxin is administered, to the frontalis at about twenty units divided among four sites of injection; to the corrugator at about ten units divided among two sites of injection; to the procerus at about five units to one site of injection; to the occipitalis at about thirty units divided among six sites of injection to about forty units divided among eight sites of injection; to the temporalis at about forty units divided among eight sites of injection up to fifty units divided among ten sites of injection; to the trapezius at about thirty units divided among six sites of injection up to about fifty units divided among ten sites of injection and to the cervical paraspinal muscles at about twenty units divided among four sites of injection; wherein the botulinum neurotoxin is injected at 31 to 39 injection sites. 2. The method of claim 1 wherein the total amount of botulinum neurotoxin administered is from about 155 units to about 195 units of onabotulinumtoxinA. 3. The method of claim 1 wherein the botulinum neurotoxin is type B. 4. The method of claim 1 wherein the botulinum neurotoxin is type E. 5. The method of claim 1 wherein the botulinum neurotoxin is type A.

Details for Patent 8,501,195

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Allergan, Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	12/09/1991		2030-03-30
Allergan, Inc.	BOTOX	onabotulinumtoxina	For Injection	103000	12/09/1991		2030-03-30

International Patent Family for US Patent 8,501,195

Country	Patent Number	Estimated Expiration
Australia	2005216887
Australia	2011201107
Australia	2011211375
Australia	2013201670
Australia	2014204554