IP Library › Patent Application 15880697
Patent Application
App. No. 15/880,697

METHODS COMPRISING DESMOPRESSIN

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Patent No.
US None
App. No.
15/880,697
Abstract

The present disclosure is directed to gender, age, and dose effects of desmopressin on reducing nocturnal voids, increasing an initial period of undisturbed sleep, and/or reducing nocturnal urine volume.

Claims (37)

1 - 140 . (canceled)

141 . A method for treating nocturia or nocturnal polyuria to increase the initial period of undisturbed sleep in a patient in need thereof based on the patient's gender comprising:

determining the gender of the patient; and

administering to the patient an orodispersible dose of desmopressin prior to bedtime over a treatment period, the dose chosen from 10 μg or 25 μg of desmopressin for a female patient and 50 μg for a male patient,

wherein the dose is measured as the free base of desmopressin.

142 . The method according to claim 141 , wherein the orodispersible dose of desmopressin is a dosage form comprising desmopressin acetate, gelatin, mannitol, and citric acid.

143 . The method according to claim 141 , wherein the dose is taken once daily.

144 . The method accordingly to claim 141 , wherein the dose of desmopressin free base is supplied in the form of the acetate salt of desmopressin.

145 . The method according to claim 141 , wherein the dose is taken from 0.8 to 3 hours prior to the patient's bedtime.

146 . The method according to claim 141 , wherein the dose is taken approximately 1 hour prior to the patient's bedtime.

147 . The method according to claim 141 , wherein the dose is taken without water.

148 . The method according to claim 141 , wherein the patient is over 65 years of age with a serum sodium level of at least 135 mmol/L after administration.

149 . The method according to claim 141 , wherein the treatment period ranges from about 3 months to about 3 years.

150 . A method for treating nocturia or nocturnal polyuria to reduce nocturnal voids in a patient in need thereof based on the patient's gender comprising:

determining the gender of the patient; and

administering to the patient an orodispersible dose of desmopressin prior to bedtime over a treatment period, the dose chosen from 10 μg or 25 μg of desmopressin for a female patient and 25 μg or 50 μg for a male patient,

wherein the dose is measured as the free base of desmopressin.

151 . The method according to claim 150 , wherein the orodispersible dose of desmopressin is a dosage form comprising desmopressin acetate, gelatin, mannitol, and citric acid.

152 . The method according to claim 150 , wherein the dose is taken once daily.

153 . The method accordingly to claim 150 , wherein the dose of desmopressin free base is supplied in the form of the acetate salt of desmopressin.

154 . The method according to claim 150 , wherein the dose is taken from 0.8 to 3 hours prior to the patient's bedtime.

155 . The method according to claim 150 , wherein the dose is taken approximately 1 hour prior to the patient's bedtime.

156 . The method according to claim 150 , wherein the dose is taken without water.

157 . The method according to claim 150 , wherein the patient is over 65 years of age with a serum sodium level of at least 135 mmol/L after administration.

158 . The method according to claim 150 , wherein the treatment period ranges from about 3 months to about 3 years.

159 . A method for treating nocturia or nocturnal polyuria to reduce nocturnal urine volume in a patient in need thereof based on the patient's gender comprising:

determining the gender of the patient; and

administering to the patient an orodispersible dose of desmopressin prior to bedtime over a treatment period, the dose chosen from 10 μg or 25 μg of desmopressin for a female patient and 25 μg or 50 μg for a male patient,

wherein the dose is measured as the free base of desmopressin.

160 . The method according to claim 159 , wherein the orodispersible dose of desmopressin is a dosage form comprising desmopressin acetate, gelatin, mannitol, and citric acid.

161 . The method according to claim 159 , wherein the dose is taken once daily.

162 . The method accordingly to claim 159 , wherein the dose of desmopressin free base is supplied in the form of the acetate salt of desmopressin.

163 . The method according to claim 159 , wherein the dose is taken from 0.8 to 3 hours prior to the patient's bedtime.

164 . The method according to claim 159 , wherein the dose is taken approximately 1 hour prior to the patient's bedtime.

165 . The method according to claim 159 , wherein the dose is taken without water.

166 . The method according to claim 159 , wherein the patient is over 65 years of age with a serum sodium level of at least 135 mmol/L after administration.

167 . The method according to claim 159 , wherein the treatment period ranges from about 3 months to about 3 years.