Methods comprising desmopressin

• US 9,974,826 B2
• Filed: 05/21/2009
• Issued: 05/22/2018
• 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 Mimer, Norgaard, Jens Peter, Shumel, Brad
• Primary Examiner(s): Chernyshev, Olga N
• Application Number:
  US12/469,801
• Publication Number:
  US 20090291880A1
• Time in Patent Office: 3,288 Days
• Field of Search: None
• CPC Class Codes: A61K 38/095 Oxytocins; Vasopressins; Related peptides
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 13/10 of the bladder
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 5/10 of the posterior pituitary hormones, e.g. oxytocin, ADH

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

1. A method for reducing nocturnal urine volume 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 135 mmol/L, prior to bedtime an orodispersible dose of desmopressin of 50 μ

g or 100 μ

g, wherein the dose is measured as the free base of desmopressin;

measuring the patient'"'"'s serum sodium level at a time interval after administration;

continuing the administration of the dose of desmopressin over a treatment period if the male patient has a serum sodium level of at least 130 mmol/L;

wherein the dose administered over the treatment period reduces the patient'"'"'s nocturnal urine volume.

2. The method according to claim 1, wherein the time interval ranges from 4 days to 28 days.

3. The method according to claim 2, wherein the time interval is 4 days.

4. The method according to claim 2, wherein the time interval is 28 days.

5. The method according to claim 1, wherein the dose is taken from 0.8 to 3 hours prior to the patient'"'"'s bedtime.

6. The method according to claim 1, wherein the dose is taken once daily.

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

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

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

10. The method according to claim 1, wherein the treatment period is 28 days.

11. The method according to claim 1, wherein the patient has a rate of urine production during sleep that is greater than the patient'"'"'s overall average daily rate of urine production.

12. The method according to claim 1, wherein the patient is over 65 years of age with a serum sodium level of at least 135 mmol/L after administration.

22. The method according to claim 1, wherein the dose of desmopressin free base is 50 μ

g.

23. The method according to claim 5, wherein the dose is taken approximately 1 hour prior to the patient'"'"'s bedtime.

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

13. A method for treating nocturia in a patient in need thereof based on the patient'"'"'s gender comprising:

determining the gender and the age 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 μ

g or 25 μ

g of desmopressin for a female patient 65 years and younger, 25 μ

g for a female patient over 65 years, and 50 μ

g or 100 μ

g for a male patient with a serum sodium level of at least 135 mmol/L,

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

wherein when the patient is male,

measuring the male patient'"'"'s serum sodium level prior to administration,

measuring the male patient'"'"'s serum sodium level at a time interval after administration, and

continuing the administration of the dose of desmopressin to the male patient over a treatment period if the male patient has a serum sodium level of at least 130 mmol/L.

14. The method according to claim 13, wherein the dose is taken from 0.8 to 3 hours prior to the patient'"'"'s bedtime.

15. The method according to claim 13, wherein the dose is taken once daily.

16. The method according to claim 13, wherein the dose of desmopressin free base is supplied in the form of the acetate salt of desmopressin.

17. The method according to claim 13, wherein the orodispersible dose of desmopressin is a dosage form comprising desmopressin acetate, gelatin, mannitol, and citric acid.

18. The method according to claim 13, wherein the patient in need thereof has nocturia or nocturnal polyuria.

19. The method according to claim 13, wherein the treatment period is 28 days.

20. The method according to claim 13, wherein the female patient over 65 or the male patient has a rate of urine production during sleep that is greater than the patient'"'"'s overall average daily rate of urine production.

21. The method according to claim 13, wherein the male patient is over 65 years of age with a serum sodium level of at least 135 mmol/L after administration.

24. The method according to claim 14, wherein the dose is taken approximately 1 hour prior to the patient'"'"'s bedtime.

26. The method according to claim 13, wherein the dose is taken without water.

27. A method for reducing nocturnal urine volume 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 135 mmol/L, approximately 1 hour prior to bedtime an orodispersible dose of desmopressin of 50 μ

g without water, wherein the dose is measured as the free base of desmopressin;

measuring the patient'"'"'s serum sodium level at a time interval after administration;

continuing the administration of the dose of desmopressin over a treatment period if the male patient has a serum sodium level of at least 130 mmol/L;

wherein the dose administered over the treatment period reduces the patient'"'"'s nocturnal urine volume.

28. A method for treating nocturia in a patient in need thereof based on the patient'"'"'s gender comprising:

determining the gender and the age of the patient; and

administering to the patient an orodispersible dose of desmopressin approximately 1 hour prior to bedtime without water, wherein the dose is chosen from 25 μ

g of desmopressin for a female patient and 50 μ

g for a male patient with a serum sodium level of at least 135 mmol/L,

wherein the dose is measured as the free base of desmopressin and wherein when the patient is male,

measuring the male patient'"'"'s serum sodium level prior to administration,

measuring the male patient'"'"'s serum sodium level at a time interval after administration, and

continuing the administration of the dose of desmopressin to the male patient over a treatment period if the male patient has a serum sodium level of at least 130 mmol/L.