METHODS OF TREATING PAINS ASSOCIATED WITH NEUROMA, NERVE ENTRAPMENT, AND OTHER CONDITIONS

• US 20110112189A1
• Filed: 05/04/2010
• Published: 05/12/2011
• Est. Priority Date: 05/04/2009
• Status: Active Grant

• Current Assignee: Nuvo Pharmaceuticals Inc. (Searchlight Pharma, Inc.)
• Original Assignee: Nuvo Pharmaceuticals Inc. (Searchlight Pharma, Inc.)
• Inventors: Zhang, Jie, Lippert, Robert
• Granted Patent: US 9,186,273 B2
• Time in Patent Office: Days
• US Class Current: 514/537
• CPC Class Codes: A61F 2007/0071 using a resistor, e.g. near the spot to be heated
• CPC Class Codes: A61F 2007/0261 medicated
• CPC Class Codes: A61F 2007/0292 using latent heat produced or absorbed during phase change of materials, e.g. of super-cooled solutions
• CPC Class Codes: A61F 7/02 Compresses or poultices for effecting heating or cooling
• CPC Class Codes: A61F 7/03 thermophore, i.e. self-heating, e.g. using a chemical reaction
• CPC Class Codes: A61F 7/034 Flameless
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/245 Amino benzoic acid types, e.g. procaine, novocaine salicylic acid esters A61K31/60
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 23/02 Local anaesthetics
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

The present disclosure is drawn to methods for treating nerve entrapment pain; neuroma pain; headache associated with neuralgia; connective tissue pain such as iliotibial band pain, blood vessel pain, tendinopathy pain, medial tibial stress syndrome pain, bursitis, etc.; arthritis pain such as osteoarthritis pain or rheumatoid arthritis pain; pain associated with injury such as fracture, severance, break, sprain, strain, tear, point pain, (e.g., trigger point pain or hit point pain), focal pain, or bruise; or combinations of these pains. Specifically, a method for treating various types of pain includes the application of an analgesic system to a skin surface of a subject experiencing the pain and maintaining the analgesic system on the skin surface for a period of time of at least 30 minutes. The analgesic system applied to the skin surface can include a heating component and a local anesthetic formulation which includes at least one local anesthetic. The heating component can be capable of heating the skin surface to a temperature of 36° C. to 42° C.

Claims

1. A method for treating nerve entrapment pain, comprising:

a) applying an analgesic system to a skin surface of a subject experiencing nerve entrapment pain, said analgesic system comprising;

i) a heating component capable of heating the skin surface to a temperature of 36°

C. to 42°

C., and

ii) a local anesthetic formulation including at least one local anesthetic; and

b) maintaining the analgesic system on the skin surface for a period of time of at least 30 minutes.

2. The method of claim 1, wherein the heating component begins heating at about the same time as the analgesic system is applied to the skin surface.

3. The method of claim 1, wherein the local anesthetic is selected from the group of tetracaine, lidocaine, prilocalne, ropivacaine, bupivacaine, benzocaine, and combinations thereof.

4. The method of claim 1, wherein the local anesthetic formulation includes at least one of lidocaine base or tetracaine base.

5. The method of claim 1, wherein the local anesthetic is a eutectic mixture of lidocaine base and tetracaine base.

6. The method of claim 5, wherein the weight percentage of the eutectic mixture is at least 30 wt % of the local anesthetic formulation.

7. The method of claim 1, wherein the analgesic system is maintained on the skin surface for a period of time of at least 60 minutes.

8. The method of claim 1, wherein the analgesic system is maintained on the skin surface for a period of time of at least two hours.

9. The method of claim 1, wherein the local anesthetic formulation has a skin contact region having an area of 2 cm² to 200 cm².

10. The method of claim 1, wherein the local anesthetic formulation has a skin contact region having an area of 7 cm² to 150 cm².

11. The method of claim 1, wherein the local anesthetic formulation has a skin contact region, said skin contact region having an area of 8 cm² to 15 cm².

12. The method of claim 1, wherein the local anesthetic formulation is applied to the skin surface directly over a site of the nerve entrapment pain.

13. The method of claim 1, wherein the nerve entrapment pain is caused by carpal tunnel syndrome.

14. The method of claim 1, wherein the nerve entrapment pain is caused by ulnar neuropathy.

15. The method of claim 1, wherein the nerve entrapment pain is caused by pudendal nerve entrapment.

16. A method for treating pain associated with neuroma, comprising:

a) applying an analgesic system to a skin surface of a subject experiencing neuroma pain, said analgesic system comprising;

i) a heating component capable of heating the skin surface to a temperature of 36°

C. to 42°

C., and

ii) a local anesthetic formulation including at least one local anesthetic; and

b) maintaining the analgesic system on the skin surface for a period of time of at least 30 minutes

17. The method of claim 16, wherein the heating component begins heating at about the same time as the analgesic system is applied to the skin surface.

18. The method of claim 16, wherein the local anesthetic is selected from the group of tetracaine, lidocaine, prilocalne, ropivacaine, bupivacaine, benzocaine, and combinations thereof.

19. The method of claim 16, wherein the local anesthetic formulation includes at least one of lidocaine base or tetracaine base.

20. The method of claim 16, wherein the local anesthetic is a eutectic mixture of lidocaine base and tetracaine base.

21. The method of claim 20, wherein the weight percentage of the eutectic mixture is at least 30 wt % of the local anesthetic formulation.

22. The method of claim 16, wherein the analgesic system is maintained on the skin surface for a period of time of at least 60 minutes.

23. The method of claim 16, wherein the analgesic system is maintained on the skin surface for a period of time of at least two hours.

24. The method of claim 16, wherein the local anesthetic formulation has a skin contact region having an area of 2 cm² to 200 cm².

25. The method of claim 16, wherein the local anesthetic formulation has a skin contact region having an area of 7 cm² to 150 cm².

26. The method of claim 16, wherein the local anesthetic formulation has a skin contact region, said skin contact region having an area of 8 cm² to 15 cm².

27. The method of claim 16, wherein the local anesthetic formulation is applied to the skin surface directly over a site of the neuroma pain.

28. The method of claim 16, wherein the neuroma pain is caused by a neoplastic tumor.

29. The method of claim 16, wherein the neuroma pain is caused by a nerve injury.

30. The method of claim 16, wherein the neuroma pain is caused by surgery.

31. The method of claim 16, wherein the neuroma pain is Morton'"'"'s neuroma.

32. A method for treating a headache, comprising:

a) applying an analgesic system to a skin surface of a subject experiencing a headache, said analgesic system comprising;

i) a heating component capable of heating the skin surface to a temperature of 36°

C. to 42°

C., and

ii) a local anesthetic formulation including at least one local anesthetic; and

b) maintaining the analgesic system on the skin surface for a period of time of at least 30 minutes.

33. The method of claim 32, wherein the heating component begins heating at about the same time as the analgesic system is applied to the skin surface.

34. The method of claim 32, wherein the local anesthetic is selected from the group of tetracaine, lidocaine, prilocalne, ropivacaine, bupivacaine, benzocaine, and combinations thereof.

35. The method of claim 32, wherein the local anesthetic formulation includes at least one of lidocaine base or tetracaine base.

36. The method of claim 32, wherein the local anesthetic is a eutectic mixture of lidocaine base and tetracaine base.

37. The method of claim 36, wherein the weight percentage of the eutectic mixture is at least 30 wt % of the local anesthetic formulation.

38. The method of claim 32, wherein the analgesic system is maintained on the skin surface for a period of time of at least 60 minutes.

39. The method of claim 32, wherein the analgesic system is maintained on the skin surface for a period of time of at least two hours.

40. The method of claim 32, wherein the local anesthetic formulation has a skin contact region having an area of 2 cm² to 200 cm².

41. The method of claim 32, wherein the local anesthetic formulation has a skin contact region having an area of 7 cm² to 150 cm².

42. The method of claim 32, wherein the local anesthetic formulation has a skin contact region, said skin contact region having an area of 8 cm² to 15 cm².

43. The method of claim 32, wherein the local anesthetic formulation is applied to a skin surface over a neck muscle or a skin surface of the head.

44. The method of claim 32, wherein the headache is from trigeminal neuralgia.

45. The method of claim 32, wherein the headache is from occipital neuralgia.

46. A method for treating connective tissue pain, comprising:

a) applying an analgesic system to a skin surface of a subject experiencing connective tissue pain, said analgesic system comprising;

i) a heating component capable of heating the skin surface to a temperature of 36°

C. to 42°

C., and

ii) a local anesthetic formulation including at least one local anesthetic; and

b) maintaining the analgesic system on the skin surface for a period of time of at least 30 minutes.

47. The method of claim 46, wherein the heating component begins heating at about the same time as the analgesic system is applied to the skin surface.

48. The method of claim 46, wherein the local anesthetic is selected from the group of tetracaine, lidocaine, prilocalne, ropivacaine, bupivacaine, benzocaine, and combinations thereof.

49. The method of claim 46, wherein the local anesthetic formulation includes at least one of lidocaine base or tetracaine base.

50. The method of claim 46, wherein the local anesthetic is a eutectic mixture of lidocaine base and tetracaine base.

51. The method of claim 50, wherein the weight percentage of the eutectic mixture is at least 30 wt % of the local anesthetic formulation.

52. The method of claim 46, wherein the analgesic system is maintained on the skin surface for a period of time of at least 60 minutes.

53. The method of claim 46, wherein the analgesic system is maintained on the skin surface for a period of time of at least two hours.

54. The method of claim 46, wherein the local anesthetic formulation has a skin contact region having an area of 2 cm² to 200 cm².

55. The method of claim 46, wherein the local anesthetic formulation has a skin contact region having an area of 7 cm² to 150 cm².

56. The method of claim 46, wherein the local anesthetic formulation has a skin contact region, said skin contact region having an area of 8 cm² to 15 cm².

57. The method of claim 46, wherein the local anesthetic formulation is applied to the skin surface directly over the connective tissue pain.

58. The method of claim 46, wherein the connective tissue pain is ligament pain.

59. The method of claim 46, wherein the connective tissue pain is tendon pain.

60. The method of claim 46, wherein the connective tissue pain is iliotibial band pain.

61. The method of claim 46, wherein the connective tissue pain is associated with a blood vessel.

62. The method of claim 46, wherein the connective tissue pain is caused by tendinopathy.

63. The method of claim 62, wherein the tendinopathy is clavicular tendonitis.

64. The method of claim 62, wherein the tendinopathy is tennis elbow.

65. The method of claim 62, wherein the tendinopathy is medial tibial stress syndrome.

66. The method of claim 46, wherein the connective tissue pain is bursitis.

67. A method for treating pain as a result of tissue damaged by fracture, sever, break, sprain, strain, tear, or bruise, comprising:

a) applying an analgesic system to a skin surface of a subject experiencing pain associated with tissue fracture, severance, break, sprain, strain, tear, bruise, focal pain, point pain, said analgesic system comprising;

i) a heating component capable of heating the skin surface to a temperature of 36°

C. to 42°

C., and

ii) a local anesthetic formulation including at least one local anesthetic; and

b) maintaining the analgesic system on the skin surface for a period of time of at least 30 minutes.

68. The method of claim 67, wherein the heating component begins heating at about the same time as the analgesic system is applied to the skin surface.

69. The method of claim 67, wherein the local anesthetic is selected from the group of tetracaine, lidocaine, prilocalne, ropivacaine, bupivacaine, benzocaine, and combinations thereof.

70. The method of claim 67, wherein the local anesthetic formulation includes at least one of lidocaine base or tetracaine base.

71. The method of claim 67, wherein the local anesthetic is a eutectic mixture of lidocaine base and tetracaine base.

72. The method of claim 71, wherein the weight percentage of the eutectic mixture is at least 30 wt % of the local anesthetic formulation.

73. The method of claim 67, wherein the analgesic system is maintained on the skin surface for a period of time of at least 60 minutes.

74. The method of claim 67, wherein the analgesic system is maintained on the skin surface for a period of time of at least two hours.

75. The method of claim 67, wherein the local anesthetic formulation has a skin contact region having an area of 2 cm² to 200 cm².

76. The method of claim 67, wherein the local anesthetic formulation has a skin contact region having an area of 7 cm² to 150 cm².

77. The method of claim 67, wherein the local anesthetic formulation has a skin contact region, said skin contact region having an area of 8 cm² to 15 cm².

78. The method of claim 67, wherein the local anesthetic formulation is applied to the skin surface directly over the pain.

79. The method of claim 67, wherein the pain is from a bone fracture.

80. The method of claim 67, wherein the pain is from surgically induced tissue sever.

81. The method of claim 67, wherein the pain is from a bone or cartilage tissue break.

82. The method of claim 67, wherein the pain is from a joint sprain or strain.

83. The method of claim 67, wherein the pain is from a tissue tear.

84. The method of claim 67, wherein the pain is from a bruise.

85. The method of claim 67, wherein the pain is focal pain.

86. The method of claim 67, wherein the pain is point pain.

87. The method of claim 67, wherein the pain is trigger point pain.

88. A method for treating pain associated with arthritis, comprising:

a) applying an analgesic system to a skin surface of a subject experiencing arthritis pain, said analgesic system comprising;

i) a heating component capable of heating the skin surface to a temperature of 36°

C. to 42°

C., and

ii) a local anesthetic formulation including at least one local anesthetic; and

b) maintaining the analgesic system on the skin surface for a period of time of at least 30 minutes.

89. The method of claim 88, wherein the heating component begins heating at about the same time as the analgesic system is applied to the skin surface.

90. The method of claim 88, wherein the local anesthetic is selected from the group of tetracaine, lidocaine, prilocalne, ropivacaine, bupivacaine, benzocaine, and combinations thereof.

91. The method of claim 88, wherein the local anesthetic formulation includes at least one of lidocaine base or tetracaine base.

92. The method of claim 88, wherein the local anesthetic is a eutectic mixture of lidocaine base and tetracaine base.

93. The method of claim 92, wherein the weight percentage of the eutectic mixture is more than 30% of the weight of the local anesthetic formulation.

94. The method of claim 88, wherein the analgesic system is maintained on the skin surface for a period of time of at least 60 minutes.

95. The method of claim 88, wherein the analgesic system is maintained on the skin surface for a period of time of at least two hours.

96. The method of claim 88, wherein the local anesthetic formulation has a skin contact region having an area of 2 cm² to 200 cm².

97. The method of claim 88, wherein the local anesthetic formulation has a skin contact region having an area of 7 cm² to 150 cm².

98. The method of claim 88, wherein the local anesthetic formulation has a skin contact region, said skin contact region having an area of 8 cm² to 15 cm².

99. The method of claim 88, wherein the local anesthetic formulation is applied to the skin surface directly over a site of the arthritis pain.

100. The method of claim 88, wherein the arthritis pain is from rheumatoid arthritis.

101. The method of claim 88, wherein the arthritis pain is from osteoarthritis.