Methods comprising desmopressin

• US 10,137,167 B2
• Filed: 12/30/2013
• Issued: 11/27/2018
• Est. Priority Date: 05/21/2008
• Status: Active Grant

• Current Assignee: Ferring BV (Ferring Holding SA)
• Original Assignee: Ferring BV (Ferring Holding SA)
• Inventors: Klein, Bjarke Mirner, Norgaard, Jens Peter
• Primary Examiner(s): Chernyshev, Olga N
• Application Number:
  US14/143,866
• Publication Number:
  US 20140113863A1
• Time in Patent Office: 1,793 Days
• Field of Search: None
• CPC Class Codes: A61K 38/08 Peptides having 5 to 11 amino acids A61K38/043 - A61K38/046 take precedence
• CPC Class Codes: A61K 38/095 Oxytocins; Vasopressins; Related peptides
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61P 13/10 of the bladder

Abstract

The present disclosure is directed to reducing nocturnal voids by administering a dose of desmopressin over a minimum treatment period compared to before administration, and maintaining or improving the reduction of nocturnal voids over the minimum treatment period.

Claims

1. A method of further reducing nocturnal voids in a male patient in need thereof comprising:

measuring the patient'"'"'s serum sodium level;

administering to the patient, with a serum sodium level of at least 130 mmol/L, prior to bedtime an orodispersible dose of desmopressin chosen from 25 μ

g, 50 μ

g, and 100 μ

g over a first treatment period of about 28 days, wherein the dose is taken from 0.8 to 3 hours prior to the patient'"'"'s bedtime and once daily;

measuring the patient'"'"'s serum sodium level after the first treatment period; and

continuing to administer the orodisperible dose of desmopressin prior to bedtime over a second contiguous treatment period of at least 28 days to about 1 year if the male patient has a serum sodium level of at least 130 mmol/L,

wherein the nocturnal voids over the second treatment period are further reduced in view of the reduction in the nocturnal voids over the first treatment period and wherein the reduction in the nocturnal voids over the first treatment period is determined based on the patient'"'"'s nocturnal voids before administration of the orodispersible dose of desmopressin for the first treatment period.

2. The method according to claim 1, wherein the dose of desmopressin free base is supplied in the form of the acetate salt of desmopressin.

3. The method according to claim 1, wherein the orodispersible dose of desmopressin is a dosage form comprising desmopressin acetate, gelatin, mannitol, and citric acid.

4. The method according to claim 1, wherein the patient in need thereof has nocturia or nocturnal polyuria.

5. The method according to claim 1, wherein the reduction in nocturnal voids ranges from about one nocturnal void to about two nocturnal voids compared to the patient'"'"'s nocturnal voids before administration of the dose.

6. The method according to claim 1, wherein the second contiguous treatment period ranges from about 8 weeks to about 1 year.

7. The method according to claim 1, wherein the second contiguous period is selected from about 8 weeks, about 12 weeks, about 20 weeks, about 28 weeks, and about 52 weeks.

8. The method according to claim 7, wherein the second contiguous period is about 8 weeks.

9. The method according to claim 7, wherein the second contiguous period is about 20 weeks.

10. The method according to claim 7, wherein the second contiguous period is about 52 weeks.

11. The method according to claim 1, wherein the second contiguous treatment period is about 1 year.

12. The method according to claim 1, wherein the dose is taken without water.

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