Claims for Patent: 7,300,412

Summary for Patent: 7,300,412

Title:	Methods for therapeutic treatment of carpal tunnel syndrome
Abstract:	A method of treating and/or preventing carpal tunnel syndrome (CTS) is provided, comprising administering a therapeutically effective amount of a botulinum toxin to a patient in need thereof or a patient at risk for development of CTS. More specifically, the method includes one or more injections of a botulinum toxin over a period of time into one or more muscles of the hand and/or wrist, or directly into the carpal tunnel along the median nerve. Pharmaceutical compositions are provided as are combination therapies with other agents such as anti-inflammatory drugs, growth factors, and agents useful in the treatment of neuropathic pain. The use of the methods of the present invention are also contemplated with other treatment regimens used to treat patients having carpal tunnel syndrome.
Inventor(s):	Pappagallo; Marco (New York, NY), Breuer; Brenda (New York, NY)
Assignee:	Hospital for Joint Diseases (New York, NY)
Application Number:	10/435,504
Patent Claims:	1. A method of reducing pain and paresthesias in a subject suffering from carpal tunnel syndrome (CTS), comprising administering a therapeutically effective amount of a botulinum toxin to a subject in need thereof, wherein the botulinum toxin is conjugated to, or combined with, a growth factor having specific receptors on the median nerve. 2. The method of claim 1, wherein the growth factor is selected from the group consisting of IGF-I, IGF-III and glial derived neurotrophic factor. 3. The method of claim 1, wherein the botulinum toxin is administered in two or more equal injections. 4. The method of claim 1, wherein the botulinum toxin is administered in three equal injections. 5. The method of claim 1, wherein the botulinum toxin is administered into the muscles of the palm, wrist or hand, and wherein the muscles treated are one or more muscles selected from the group consisting of the palmaris brevis muscle, the opponens digiti minimi muscle, and flexor digiti minimi muscle. 6. The method of claim 1, wherein the reducing of pain and paresthesias is accompanied by a decrease of the internal carpal tunnel (CT) pressure and a lessening of the entrapment of the median nerve within the CT. 7. The method of claim 6, wherein treatment is repeated over a period of time as needed by the patient being treated. 8. The method of claim 6, wherein the botulinum toxin is administered in two or more equal injections. 9. The method of claim 6, wherein the botulinum toxin is administered in three equal injections. 10. The method of either one of claims 1 or 6, wherein the botulinum toxin is a type B toxin. 11. The method of claim 10, wherein the botulinum toxin type B is Myobloc.TM.. 12. The method of claim 6, wherein the total amount of Myobloc.TM. injected is up to 10,000 units. 13. The method of claim 6, wherein the total amount of Myobloc.TM. injected is between about 2500-7500 units. 14. The method of either one of claims 1 or 6, wherein the botulinum toxin is a type A toxin. 15. The method of claim 14, wherein the botulinum toxin type A is Botox.TM.. 16. The method of claim 15, wherein the total amount of Botox.TM. injected is up to 200 units. 17. The method of claim 16, wherein the total amount of Botox.TM. injected is between about 10-100 units. 18. A method of treating carpal tunnel syndrome (CTS), comprising administration of a therapeutically effective amount of an agent capable of diminishing pain and paresthesias in a subject in need of such therapy, wherein the diminishing pain and paresthesias are accompanied by a decrease of the internal carpal tunnel (CT) pressure and a lessening of the entrapment of the median nerve within the CT. 19. The method of claim 18, wherein the administration comprises intramuscular injection into one or more muscles selected from the group consisting of the palmaris brevis muscle, the opponens digiti minimi muscle, and flexor digiti minimi muscle. 20. A method of treating carpal tunnel syndrome (CTS), comprising intramuscular administration of a therapeutically effective amount of an agent capable of diminishing pain and paresthesias in a subject in need of such therapy, wherein said administration is by injection of the agent into one or more of the muscles selected from the group consisting of the palmaris brevis muscle, the opponens digiti minimi muscle, and flexor digiti minimi muscle and is accompanied by a decrease of the internal carpal tunnel (CT) pressure, and a lessening of the entrapment of the median nerve within the CT. 21. The method of claim 20, wherein the method comprises administration of a botulinum toxin or an agent having similar biological/functional properties. 22. The method of claim 21, wherein the botulinum toxin is a type B toxin. 23. The method of claim 22, wherein the botulinum toxin type B is Myobloc.TM.. 24. The method of claim 21, wherein the botulinum toxin is a type A toxin. 25. The method of claim 24, wherein the botulinum toxin type A is Botox.TM.. 26. A method of treating carpal tunnel syndrome, comprising combination therapy of a botulinum toxin with a second agent or treatment regimen shown to be effective in treatment of carpal tunnel syndrome, wherein the second agent or treatment regimen is selected from the group consisting of corticosteroids, non-steroidal anti-inflammatory compounds (NSAIDs) including COX-1 and COX-2 inhibitors, growth factors, a compound effective in treating neuropathic pain, surgery and a brace used to immobilize the wrist, wherein the COX-1 inhibitor is selected from the group consisting of ibuprofen, naproxen, and indomethacin. 27. A method of treating carpal tunnel syndrome, comprising combination therapy of a botulinum toxin with a second agent or treatment regimen shown to be effective in treatment of carpal tunnel syndrome, wherein the second agent or treatment regimen is selected from the group consisting of corticosteroids, non-steroidal anti-inflammatory compounds (NSAIDs) including COX-1 and COX-2 inhibitors, growth factors, a compound effective in treating neuropathic pain, surgery and a brace used to immobilize the wrist, wherein the COX-2 inhibitor is selected from the group consisting of celecoxib, rofecoxib and valdecoxib. 28. A method of treating carpal tunnel syndrome, comprising combination therapy of a botulinum toxin with a second agent or treatment regimen shown to be effective in treatment of carpal tunnel syndrome, wherein the second agent or treatment regimen is selected from the group consisting of corticosteroids, non-steroidal anti-inflammatory compounds (NSAIDs) including COX-1 and COX-2 inhibitors, growth factors, a compound effective in treating neuropathic pain, surgery and a brace used to immobilize the wrist, wherein the growth factors are selected from the group consisting of IGF-I, IGF-III and glial derived neurotrophic factor (GDNF). 29. A method of treating carpal tunnel syndrome, comprising combination therapy of a botulinum toxin with a second agent or treatment regimen shown to be effective in treatment of carpal tunnel syndrome, wherein the treatment regimen comprises use of a device to exercise and strengthen the hand, wrist and arm and wherein the user may perform a series of flexion and extension manipulations for both therapy and exercise to resist fatigue, to increase blood flow and to strengthen the muscles of the hand and forearm. 30. A method of treating carpal tunnel syndrome (CTS), comprising administration of a therapeutically effective amount of an agent capable of diminishing pain and paresthesias in a subject in need of such therapy, wherein said administration is by injection of the agent directly into the carpal tunnel along the median nerve and is accompanied by a decrease of the internal carpal tunnel (CT) pressure, and a lessening of the entrapment of the median nerve within the CT. 31. A pharmaceutical composition comprising a botulinum toxin effective for treatment of pain and paresthesias in patients suffering from carpal tunnel syndrome, further comprising a therapeutically effective amount of a growth factor selected from the group consisting of IGF-I, IGF-III and glial derived neurotrophic factor, and a pharmaceutically acceptable carrier, and wherein the botulinum toxin is conjugated to, or combined with, at least one of said growth factors having specific receptors on the median nerve.

Details for Patent 7,300,412

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846	12/08/2000		2022-05-10