Method of treating functional bowel disorders

• US 20040254170A1
• Filed: 05/07/2004
• Published: 12/16/2004
• Est. Priority Date: 01/13/2003
• Status: Abandoned Application

• Current Assignee: Dynogen Pharmaceuticals, Inc. (Edusa Pharmaceuticals, Inc.)
• Original Assignee: Dynogen Incorporated
• Inventors: Landau, Steven B.
• Application Number:
  US10/841,318
• Publication Number:
  US 20040254170A1
• Time in Patent Office: Days
• US Class Current: 514/218
• 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 31/505 Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• CPC Class Codes: A61K 31/551 having two nitrogen atoms, e.g. dilazep
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/12 Antidiarrhoeals
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The invention relates to a method of treating functional bowel disorders in a subject in need of treatment. The method comprises administering to a subject in need of treatment a therapeutically effective amount of a compound that has 5-HT₃ receptor antagonist activity and NorAdrenaline Reuptake Inhibitor (NARI) activity. The invention further relates to a method of treating a functional bowel disorder in a subject in need thereof, comprising coadministering to said subject a first amount of a 5-HT₃ antagonist and a second amount of a NARI, wherein the first and second amounts together comprise a therapeutically effective amount or are each present in a therapeutically effective amount. In addition, the method of the invention comprises administering a NARI alone. The functional bowel disorders which can be treated according to the method of the invention include IBS, functional abdominal bloating, functional constipation and functional diarrhea.

Claims

1-62. -62. (canceled)

63. (new) A method for treating a functional bowel disorder comprising administering from about 0.05 mg to about 500 mg per day of a compound of formula I:

64. (new) The method of claim 63, wherein said administering is in a single dosage.

65. (new) The method of claim 63, wherein said administering is in two dosages.

66. (new) The method of claim 63, wherein said administering is in three dosages.

67. (new) The method of claim 63, wherein said administering is in four dosages.

68. (new) The method of claim 63, wherein said administering is every day.

69. (new) The method of claim 63, wherein said administering is every other day, every 2 days, every 3 days, every 4 days, or every 5 days.

70. (new) The method of claim 63, wherein said administering is oral.

71. (new) The method of claim 70, wherein 0.05 mg is administered.

72. (new) The method of claim 70, wherein 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mg is administered.

73. (new) The method of claim 63, wherein the functional bowel disorder is irritable bowel syndrome.

74. (new) The method of claim 73, wherein the irritable bowel syndrome is diarrhea predominant irritable bowel syndrome.

75. (new) The method of claim 73, wherein the irritable bowel syndrome is alternating constipation/diarrhea irritable bowel syndrome.

76. (new) The method of claim 73, wherein the irritable bowel syndrome is nonconstipated irritable bowel syndrome.

77. (new) A method for treating a functional bowel disorder comprising administering from about 0.03 mg to about 300 mg per day of a compound of formula I:

78. (new) The method of claim 77, wherein said administering is in a single dosage.

79. (new) The method of claim 77, wherein said administering is in two dosages.

80. (new) The method of claim 77, wherein said administering is in three dosages.

81. (new) The method of claim 77, wherein said administering is in four dosages.

82. (new) The method of claim 77, wherein said administering is every day.

83. (new) The method of claim 77, wherein said administering is every other day, every 2 days, every 3 days, every 4 days, or every 5 days.

84. (new) The method of claim 77, wherein said administering is oral.

85. (new) The method of claim 84, wherein 0.03 or 0.05 mg is administered.

86. (new) The method of claim 84, wherein 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mg is administered.

87. (new) The method of claim 77, wherein the functional bowel disorder is irritable bowel syndrome.

88. (new) The method of claim 87, wherein the irritable bowel syndrome is diarrhea predominant irritable bowel syndrome.

89. (new) The method of claim 87, wherein the irritable bowel syndrome is alternating constipation/diarrhea irritable bowel syndrome.

90. (new) The method of claim 87, wherein the irritable bowel syndrome is nonconstipated irritable bowel syndrome.

91. (new) A method for treating a functional bowel disorder comprising administering from about 0.02 mg to about 200 mg per day of a compound of formula I:

92. (new) The method of claim 91, wherein said administering is in a single dosage.

93. (new) The method of claim 91, wherein said administering is in two dosages.

94. (new) The method of claim 91, wherein said administering is in three dosages.

95. (new) The method of claim 91, wherein said administering is in four dosages.

96. (new) The method of claim 91, wherein said administering is every day.

97. (new) The method of claim 91, wherein said administering is every other day, every 2 days, every 3 days, every 4 days, or every 5 days.

98. (new) The method of claim 91, wherein said administering is oral.

99. (new) The method of claim 98, where 0.02, 0.03, or 0.05 mg is administered.

100. (new) The method of claim 98, wherein 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mg is administered.

101. (new) The method of claim 91, wherein the functional bowel disorder is irritable bowel syndrome.

102. (new) The method of claim 101, wherein the irritable bowel syndrome is diarrhea predominant irritable bowel syndrome.

103. (new) The method of claim 101, wherein the irritable bowel syndrome is alternating constipation/diarrhea irritable bowel syndrome.

104. (new) The method of claim 101, wherein the irritable bowel syndrome is nonconstipated irritable bowel syndrome.

105. (new) A method for treating a functional bowel disorder comprising administering from about 0.1 mg to about 50 mg per day of a compound of formula I:

106. (new) The method of claim 105, wherein said administering is in a single dosage.

107. (new) The method of claim 105, wherein said administering is in two dosages.

108. (new) The method of claim 105, wherein said administering is in three dosages.

109. (new) The method of claim 105, wherein said administering is in four dosages.

110. (new) The method of claim 105, wherein said administering is every day.

111. (new) The method of claim 105, wherein said administering is every other day, every 2 days, every 3 days, every 4 days, or every 5 days.

112. (new) The method of claim 105, wherein said administering is oral.

113. (new) The method of claim 112, wherein 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mg is administered.

114. (new) The method of claim 105, wherein the functional bowel disorder is irritable bowel syndrome.

115. (new) The method of claim 114, wherein the irritable bowel syndrome is diarrhea predominant irritable bowel syndrome.

116. (new) The method of claim 114, wherein the irritable bowel syndrome is alternating constipation/diarrhea irritable bowel syndrome.

117. (new) The method of claim 114, wherein the irritable bowel syndrome is nonconstipated irritable bowel syndrome.

118. (new) A method for treating a functional bowel disorder comprising administering from about 0.5 mg to about 10 mg per day of a compound of formula I:

119. (new) The method of claim 118, wherein said administering is in a single dosage.

120. (new) The method of claim 118, wherein said administering is in two dosages.

121. (new) The method of claim 118, wherein said administering is in three dosages.

122. (new) The method of claim 118, wherein said administering is in four dosages.

123. (new) The method of claim 118, wherein said administering is every day.

124. (new) The method of claim 118, wherein said administering is every other day, every 2 days, every 3 days, every 4 days, or every 5 days.

125. (new) The method of claim 118, wherein said administering is oral.

126. (new) The method of claim 125, wherein 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mg is administered.

127. (new) The method of claim 118, wherein the functional bowel disorder is irritable bowel syndrome.

128. (new) The method of claim 127, wherein the irritable bowel syndrome is diarrhea predominant irritable bowel syndrome.

129. (new) The method of claim 127, wherein the irritable bowel syndrome is alternating constipation/diarrhea irritable bowel syndrome.

130. (new) The method of claim 127, wherein the irritable bowel syndrome is nonconstipated irritable bowel syndrome.