Method of treating lower urinary tract disorders

• US 20050026909A1
• Filed: 06/07/2004
• Published: 02/03/2005
• Est. Priority Date: 04/04/2003
• Status: Active Grant

• Current Assignee: Edusa Pharmaceuticals, Inc.
• Original Assignee: Dynogen Incorporated
• Inventors: Landau, Steven B., Fraser, Matthew O., Miller, Cheryl L.
• Granted Patent: US 7,115,606 B2
• 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 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/551 having two nitrogen atoms, e.g. dilazep
• CPC Class Codes: A61K 31/5513 1,4-Benzodiazepines, e.g. diazepam or clozapine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 13/08 of the prostate
• CPC Class Codes: A61P 13/10 of the bladder
• 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 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The invention relates to a method of treating at least one symptom of a lower urinary tract disorder in a subject in need of treatment wherein the symptom is selected from the group consisting of urinary frequency, urinary urgency, urinary urge incontinence, nocturia and enuresis. 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 at least one symptom of a lower urinary tract disorder in a subject in need of treatment wherein the symptom is selected from the group consisting of urinary frequency, urinary urgency, urinary urge incontinence, nocturia and enuresis, 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.

Claims

1-70. -70. (canceled)

71. A method for treating nocturia comprising administering a therapeutically effective amount of a compound of formula I:

72. The method of claim 71, wherein said administering is oral.

73. The method of claim 71, wherein said administering is on an as-needed basis.

74. The method of claim 71, wherein said therapeutically effective amount is from about 0.001 to about 1000 mg per day.

75. The method of claim 71, wherein said therapeutically effective amount is from about 0.05 to about 500 mg per day.

76. The method of claim 71, wherein said therapeutically effective amount is from about 0.03 to about 300 mg per day.

77. The method of claim 71, wherein said therapeutically effective amount is from about 0.02 to about 200 mg per day.

78. The method of claim 71, wherein said therapeutically effective amount is from about 0.1 to about 50 mg per day.

79. A method for treating nocturia comprising administering a therapeutically effective amount of a compound of formula II:

80. The method of claim 79, wherein said administering is oral.

81. The method of claim 79, wherein said administering is on an as-needed basis.

82. The method of claim 79, wherein said therapeutically effective amount is from about 0.001 to about 1000 mg per day.

83. The method of claim 79, wherein said therapeutically effective amount is from about 0.05 to about 500 mg per day.

84. The method of claim 79, wherein said therapeutically effective amount is from about 0.03 to about 300 mg per day.

85. The method of claim 79, wherein said therapeutically effective amount is from about 0.02 to about 200 mg per day.

86. The method of claim 79, wherein said therapeutically effective amount is from about 0.1 to about 50 mg per day.

87. A method for treating overactive bladder without involuntary loss of urine comprising administering a therapeutically effective amount of a compound of formula I:

88. The method of claim 87, wherein said administering is oral.

89. The method of claim 87, wherein said administering is on an as-needed basis.

90. The method of claim 87, wherein said therapeutically effective amount is from about 0.001 to about 1000 mg per day.

91. The method of claim 87, wherein said therapeutically effective amount is from about 0.05 to about 500 mg per day.

92. The method of claim 87, wherein said therapeutically effective amount is from about 0.03 to about 300 mg per day.

93. The method of claim 87, wherein said therapeutically effective amount is from about 0.02 to about 200 mg per day.

94. The method of claim 87, wherein said therapeutically effective amount is from about 0.1 to about 50 mg per day.

95. A method for treating overactive bladder without involuntary loss of urine comprising administering a therapeutically effective amount of a compound of formula II:

96. The method of claim 95, wherein said administering is oral.

97. The method of claim 95, wherein said administering is on an as-needed basis.

98. The method of claim 95, wherein said therapeutically effective amount is from about 0.001 to about 1000 mg per day.

99. The method of claim 95, wherein said therapeutically effective amount is from about 0.05 to about 500 mg per day.

100. The method of claim 95, wherein said therapeutically effective amount is from about 0.03 to about 300 mg per day.

101. The method of claim 95, wherein said therapeutically effective amount is from about 0.02 to about 200 mg per day.

102. The method of claim 95, wherein said therapeutically effective amount is from about 0.1 to about 50 mg per day.

103. A method for treating at least one symptom of overactive bladder without involuntary loss of urine, wherein the symptom is selected from the group consisting of urinary frequency and urinary urgency, comprising administering a therapeutically effective amount of a compound of formula I:

104. The method of claim 103, wherein said administering is oral.

105. The method of claim 103, wherein said administering is on an as-needed basis.

106. The method of claim 103, wherein said therapeutically effective amount is from about 0.001 to about 1000 mg per day.

107. The method of claim 103, wherein said therapeutically effective amount is from about 0.05 to about 500 mg per day.

108. The method of claim 103, wherein said therapeutically effective amount is from about 0.03 to about 300 mg per day.

109. The method of claim 103, wherein said therapeutically effective amount is from about 0.02 to about 200 mg per day.

110. The method of claim 103, wherein said therapeutically effective amount is from about 0.1 to about 50 mg per day.

111. A method for treating at least one symptom of overactive bladder without involuntary loss of urine, wherein the symptom is selected from the group consisting of urinary frequency and urinary urgency, comprising administering a therapeutically effective amount of a compound of formula II:

112. The method of claim 111, wherein said administering is oral.

113. The method of claim 111, wherein said administering is on an as-needed basis.

114. The method of claim 111, wherein said therapeutically effective amount is from about 0.001 to about 1000 mg per day.

115. The method of claim 111, wherein said therapeutically effective amount is from about 0.05 to about 500 mg per day.

116. The method of claim 111, wherein said therapeutically effective amount is from about 0.03 to about 300 mg per day.

117. The method of claim 111, wherein said therapeutically effective amount is from about 0.02 to about 200 mg per day.

118. The method of claim 111, wherein said therapeutically effective amount is from about 0.1 to about 50 mg per day.