COMBINATION OF CANNABINOIDS FOR THE TREATMENT OF PERIPHERAL NEUROPATHIC PAIN

• US 20100035978A1
• Filed: 10/31/2006
• Published: 02/11/2010
• Est. Priority Date: 11/01/2005
• Status: Abandoned Application

• Current Assignee: GW Pharmaceuticals Limited (Jazz Pharmaceuticals Plc)
• Original Assignee: GW Pharmaceuticals Limited (Jazz Pharmaceuticals Plc)
• Inventors: Wright, Stephen, Robson, Philip, Guy, Geoffrey
• Application Number:
  US12/084,454
• Publication Number:
  US 20100035978A1
• Time in Patent Office: Days
• US Class Current: 514/454
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/047 having two or more hydroxy groups, e.g. sorbitol
• CPC Class Codes: A61K 31/352 condensed with carbocyclic rings, e.g. methantheline cannabinoids A61K31/658
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 29/02 without antiinflammatory effect

Abstract

The present invention relates to the use of a combination of cannabinoids in the treatment of neuropathic pain, in particular peripheral neuropathic pain. A combination of cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC) may be used, wherein the ratio of CBD:THC by weight is between 10:1 and 1:10.

Claims

1-24. -24. (canceled)

25. A method of treating peripheral neuropathic pain in a human patient comprising administering to a patient in need thereof a therapeutically effective amount of a combination of cannabinoids cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), wherein the ratio of CBD:

THC by weight is between 10;

1 and 1;

10.

30. The method as claimed in claim 25, wherein the ratio of CBD:

THC by weight is between 5;

1 and 1;

5.

31. The method as claimed in claim 25, wherein the ratio of CBD:

THC by weight is between 2;

1 and 1;

2.

32. The method as claimed in claim 25, wherein the ratio of CBD:

THC by weight is substantially 1;

1.

33. The method as claimed in claim 32, wherein the ratio of CBD:

THC by weight is 0.93;

1.

34. The method as claimed in claim 25, wherein the cannabinoids are packaged for delivery in a titratable dosage form.

35. The method as claimed in claim 25, wherein the cannabinoid CBD is administered separately, simultaneously or sequentially to the cannabinoid THC.

36. The method as claimed in claim 25, wherein a unit dose taken by a patient is in the range of 5-25 mg of each cannabinoid.

37. The method as claimed in claim 25, wherein the maximum daily dosage dose of each cannabinoid is less than or equal to 120 mg of CBD and less than or equal to 130 mg of THC.

38. The method as claimed in claim 25, wherein the pharmaceutical formulations are packaged for delivery such that delivery is targeted to an area selected from the group:

sublingual;

buccal;

oral;

rectal, nasal; and

the pulmonary system.

39. The method as claimed in claim 38, wherein the pharmaceutical formulations are in the form selected from the group:

gel;

gel spray;

tablet;

liquid;

capsule and for vaporisation.

40. The method as claimed in claim 25, wherein the cannabinoids are present as a cannabis based medicine extract (CBME).

41. The method as claimed in claim 25, wherein the combination of cannabinoids comprises:

a) a cannabis based medicinal extract which comprises THC at more than 90% of the total cannabinoid content in the extract; and

b) a cannabis based medicinal extract which comprises CBD at more than 90% of the total cannabinoid content in the extract.

42. The method as claimed in claim 25, wherein the cannabinoids are substantially pure.

43. The method as claimed in claim 25, wherein the cannabinoids are synthetic.

44. The method as claimed in claim 25, wherein the cannabinoids are administered in combination with one or more other medicinal substances.

45. The method as claimed in claim 44, wherein the cannabinoids are administered in addition to one or more analgesic drugs, one or more opiate or opiate related drugs, one or more anticonvulsant drugs and/or one or more antidepressant drugs.

46. The method as claimed in claim 44, wherein the cannabinoids are administered separately, simultaneously or sequentially to the one or more other drugs.

26. A method of treating peripheral neuropathic pain characterised by allodynia in a human patient comprising administering to a patient in need thereof a therapeutically effective amount of a combination of cannabinoids cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), wherein the ratio of CBD:

THC by weight is between 10;

1 and 1;

10.

47. The method as claimed in claim 26, wherein the ratio of CBD:

THC by weight is between 5;

1 and 1;

5.

48. The method as claimed in claim 26, wherein the ratio of CBD:

THC by weight is between 2;

1 and 1;

2.

49. The method as claimed in claim 26, wherein the ratio of CBD:

THC by weight is substantially 1;

1.

50. The method as claimed in claim 49, wherein the ratio of CBD:

THC by weight is 0.93;

1.

51. The method as claimed in claim 26, wherein the cannabinoids are packaged for delivery in a titratable dosage form.

52. The method as claimed in claim 26, wherein the cannabinoid CBD is administered separately, simultaneously or sequentially to the cannabinoid THC.

53. The method as claimed in claim 26, wherein a unit dose taken by a patient is in the range of 5-25 mg of each cannabinoid.

54. The method as claimed in claim 26, wherein the maximum daily dosage dose of each cannabinoid is less than or equal to 120 mg of CBD and less than or equal to 130 mg of THC.

55. The method as claimed in claim 26, wherein the pharmaceutical formulations are packaged for delivery such that delivery is targeted to an area selected from the group:

sublingual;

buccal;

oral;

rectal, nasal; and

the pulmonary system.

56. The method as claimed in claim 55, wherein the pharmaceutical formulations are in the form selected from the group:

gel;

gel spray;

tablet;

liquid;

capsule and for vaporisation.

57. The method as claimed in claim 26, wherein the cannabinoids are present as a cannabis based medicine extract (CBME).

58. The method as claimed in claim 26, wherein the combination of cannabinoids comprises:

a) a cannabis based medicinal extract which comprises THC at more than 90% of the total cannabinoid content in the extract; and

b) a cannabis based medicinal extract which comprises CBD at more than 90% of the total cannabinoid content in the extract.

59. The method as claimed in claim 26, wherein the cannabinoids are substantially pure.

60. The method as claimed in claim 26, wherein the cannabinoids are synthetic.

61. The method as claimed in claim 26, wherein the cannabinoids are administered in combination with one or more other medicinal substances.

62. The method as claimed in claim 61, wherein the cannabinoids are administered in addition to one or more analgesic drugs, one or more opiate or opiate related drugs, one or more anticonvulsant drugs and/or one or more antidepressant drugs.

63. The method as claimed in claim 61, wherein the cannabinoids are administered separately, simultaneously or sequentially to the one or more other drugs.

27. A method of treating peripheral neuropathic pain characterised by post-herpetic neuralgia in a human patient comprising administering to a patient in need thereof a therapeutically effective amount of a combination of cannabinoids cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), wherein the ratio of CBD:

THC by weight is between 10;

1 and 1;

10.

64. The method as claimed in claim 27, wherein the ratio of CBD:

THC by weight is between 5;

1 and 1;

5.

65. The method as claimed in claim 27, wherein the ratio of CBD:

THC by weight is between 2;

1 and 1;

2.

66. The method as claimed in claim 27, wherein the ratio of CBD:

THC by weight is substantially 1;

1.

67. The method as claimed in claim 66, wherein the ratio of CBD:

THC by weight is 0.93;

1.

68. The method as claimed in claim 27, wherein the cannabinoids are packaged for delivery in a titratable dosage form.

69. The method as claimed in claim 27, wherein the cannabinoid CBD is administered separately, simultaneously or sequentially to the cannabinoid THC.

70. The method as claimed in claim 27, wherein a unit dose taken by a patient is in the range of 5-25 mg of each cannabinoid.

71. The method as claimed in claim 27, wherein the maximum daily dosage dose of each cannabinoid is less than or equal to 120 mg of CBD and less than or equal to 130 mg of THC.

72. The method as claimed in claim 27, wherein the pharmaceutical formulations are packaged for delivery such that delivery is targeted to an area selected from the group:

sublingual;

buccal;

oral;

rectal, nasal; and

the pulmonary system.

73. The method as claimed in claim 72, wherein the pharmaceutical formulations are in the form selected from the group:

gel;

gel spray;

tablet;

liquid;

capsule and for vaporisation.

74. The method as claimed in claim 27, wherein the cannabinoids are present as a cannabis based medicine extract (CBME).

75. The method as claimed in claim 27, wherein the combination of cannabinoids comprises:

a) a cannabis based medicinal extract which comprises THC at more than 90% of the total cannabinoid content in the extract; and

b) a cannabis based medicinal extract which comprises CBD at more than 90% of the total cannabinoid content in the extract.

76. The method as claimed in claim 27, wherein the cannabinoids are substantially pure.

77. The method as claimed in claim 27, wherein the cannabinoids are synthetic.

78. The method as claimed in claim 27, wherein the cannabinoids are administered in combination with one or more other medicinal substances.

79. The method as claimed in claim 78, wherein the cannabinoids are administered in addition to one or more analgesic drugs, one or more opiate or opiate related drugs, one or more anticonvulsant drugs and/or one or more antidepressant drugs.

80. The method as claimed in claim 78, wherein the cannabinoids are administered separately, simultaneously or sequentially to the one or more other drugs.

28. A method of treating sleep disturbance caused by peripheral neuropathic pain in a human patient comprising administering to a patient in need thereof a therapeutically effective amount of a combination of a combination of cannabinoids cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), wherein the ratio of CBD:

THC by weight is between 10;

1 and 1;

10.

81. The method as claimed in claim 28, wherein the ratio of CBD:

THC by weight is between 5;

1 and 1;

5.

82. The method as claimed in claim 28, wherein the ratio of CBD:

THC by weight is between 2;

1 and 1;

2.

83. The method as claimed in claim 28, wherein the ratio of CBD:

THC by weight is substantially 1;

1.

84. The method as claimed in claim 83, wherein the ratio of CBD:

THC by weight is 0.93;

1.

85. The method as claimed in claim 28, wherein the cannabinoids are packaged for delivery in a titratable dosage form.

86. The method as claimed in claim 28, wherein the cannabinoid CBD is administered separately, simultaneously or sequentially to the cannabinoid THC.

87. The method as claimed in claim 28, wherein a unit dose taken by a patient is in the range of 5-25 mg of each cannabinoid.

88. The method as claimed in claim 28, wherein the maximum daily dosage dose of each cannabinoid is less than or equal to 120 mg of CBD and less than or equal to 130 mg of THC.

89. The method as claimed in claim 28, wherein the pharmaceutical formulations are packaged for delivery such that delivery is targeted to an area selected from the group:

sublingual;

buccal;

oral;

rectal, nasal; and

the pulmonary system.

90. The method as claimed in claim 89, wherein the pharmaceutical formulations are in the form selected from the group:

gel;

gel spray;

tablet;

liquid;

capsule and for vaporisation.

91. The method as claimed in claim 28, wherein the cannabinoids are present as a cannabis based medicine extract (CBME).

92. The method as claimed in claim 28, wherein the combination of cannabinoids comprises:

a) a cannabis based medicinal extract which comprises THC at more than 90% of the total cannabinoid content in the extract; and

b) a cannabis based medicinal extract which comprises CBD at more than 90% of the total cannabinoid content in the extract.

93. The method as claimed in claim 28, wherein the cannabinoids are substantially pure.

94. The method as claimed in claim 28, wherein the cannabinoids are synthetic.

95. The method as claimed in claim 28, wherein the cannabinoids are administered in combination with one or more other medicinal substances.

96. The method as claimed in claim 95, wherein the cannabinoids are administered in addition to one or more analgesic drugs, one or more opiate or opiate related drugs, one or more anticonvulsant drugs and/or one or more antidepressant drugs.

97. The method as claimed in claim 95, wherein the cannabinoids are administered separately, simultaneously or sequentially to the one or more other drugs.

29. (canceled)