US2018250357A1PendingUtilityA1

Methods comprising desmopressin

Assignee: FERRING BVPriority: May 21, 2008Filed: Jan 26, 2018Published: Sep 6, 2018
Est. expiryMay 21, 2028(~1.8 yrs left)· nominal 20-yr term from priority
A61P 5/10A61P 25/20A61P 13/02A61P 13/10A61P 13/00A61K 38/095A61K 38/11
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Claims

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

exact text as granted — not AI-modified
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.

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