Claims for Patent: 8,383,103

Summary for Patent: 8,383,103

Title:	Botulinum toxin compositions and methods
Abstract:	Disclosed herein are methods of using extracellular matrix digesting enzymes and neurotoxins, such as a Clostridial neurotoxins, to treat various medical conditions, such as overactive bladder, benign prostatic hyperplasia, hyperhidrosis, and cholecystitis for example.
Inventor(s):	Gaylis; Franklin D. (La Mesa, CA), Blumenfeld; Andrew M. (Del Mar, CA)
Assignee:	Allergan, Inc. (Irvine, CA) Gaylis; Franklin D. (La Mesa, CA)
Application Number:	12/032,057
Patent Claims:	1. method for treating a patient suffering from cholecystitis wherein the cholecystitis is due to the presence of at least one gall stone, comprising the steps of: a) administering either topically or by instillation a first composition containing an extracellular matrix digesting enzyme to a gall bladder surface area of the patient; b) allowing the extracellular matrix digesting enzyme to diffuse through the gall bladder surface area for between about 5 minutes and about 2 hours; c) administering either topically or by instillation a second composition containing a type A or B botulinum toxin to the gall bladder surface area; and d) allowing sufficient time for the botulinum toxin to diffuse through the gall bladder surface area to alleviate at least one symptom associated with cholecystitis, thereby treating the patient suffering from cholecystitis. 2. The method of claim 1, wherein the gall bladder surface area is within a duct of the gall bladder. 3. The method of claim 1, wherein the botulinum toxin is botulinum toxin type A. 4. The method of claim 1, wherein the botulinum toxin is a botulinum toxin type B. 5. The method of claim 1, further comprising the steps of optionally removing the first composition after step (b) and optionally removing the second composition after step (d). 6. The method of claim 1, wherein the extracellular matrix digesting enzyme is selected from the group consisting of a hyaluronidase, a tissue plasminogen activator and a collagenase. 7. The method of claim 3, wherein the botulinum toxin type A administered is from between about 1 unit to about 3000 units. 8. The method of claim 4, wherein the botulinum toxin type B administered is from about 50 units to about 25,000 units. 9. A method for administering a botulinum toxin to a patient suffering from cholecystitis due to the presence of at least one gall stone, the method comprising the steps of: a) accessing a gall bladder of the patient suffering from cholecystitis; b) administering a first composition containing at least one extracellular matrix digesting enzyme to a gall bladder surface area of the patient; and c) administering the second composition containing a botulinum toxin to the gall bladder surface area of the patient, wherein the first composition containing at least one extracellular matrix digesting enzyme and the second composition containing a botulinum toxin are instilled into the gall bladder or a duct of the gall bladder to contact the gall bladder surface area of the patient. 10. The method of claim 9, wherein the botulinum toxin is selected from the group consisting of botulinum toxin types A, B, C.sub.1, D, E, F and G. 11. The method according to claim 9, wherein the botulinum toxin is a botulinum toxin type A. 12. The method according to claim 11, wherein the amount of botulinum toxin type A administered is between about 10 units and about 2750 units. 13. The method according to claim 7, wherein the at least one extracellular matrix digesting enzyme is selected from the group consisting of a hyaluronidase, a tissue plasminogen activator and a collagenase. 14. The method according to claim 9, wherein the duct of the gall bladder dilates sufficiently subsequent to instillation of the first composition containing at least one extracellular matrix digesting enzyme and the second composition containing a botulinum toxin to allow a gall stone to pass through the duct of the gall bladder. 15. The method according to claim 1, wherein the at least one extracellular matrix digesting enzyme is a hyaluronidase and the botulinum toxin is a botulinum toxin type A.

Details for Patent 8,383,103

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	05/05/2004		2027-02-15
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	12/02/2004		2027-02-15
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10/26/2004		2027-02-15