Claims for Patent: 11,963,995

Summary for Patent: 11,963,995

Title:	Methods comprising desmopressin
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.
Inventor(s):	Bjarke Mirner Klein, Jens Peter Norgaard
Assignee:	Ferring BV
Application Number:	US17/332,327
Patent Claims:	1. A method for increasing an initial period of undisturbed sleep after going to bed in a patient in need of treatment for nocturia or nocturnal polyuria, comprising: administering to the patient prior to bedtime an orodispersible dose of desmopressin chosen from 10 μg or 25 μg, wherein the dose is measured as the free base of desmopressin and the dose taken over a treatment period increases the patient's initial period of undisturbed sleep after going to bed as compared to the patient's baseline prior to treatment. 2. The method of claim 1, wherein the patient is a male patient, and the orodispersible dose of desmopressin is 10 μg. 3. The method of claim 1, wherein the patient is a female patient aged 65 years and younger, and the orodispersible dose of desmopressin is chosen from 10 μg or 25 μg. 4. The method of claim 1, wherein the patient is a female patient aged over 65 years, and the orodispersible dose of desmopressin is 25 μg. 5. The method of claim 1, wherein the patient is a female patient, and the increase is about 46 minutes for an orodispersible dose of desmopressin of 10 μg. 6. The method of claim 1, wherein the patient is a female patient, and the increase is about 95 minutes for an orodispersible dose of desmopressin of 25 μg. 7. The method of claim 1, wherein the patient has nocturia or nocturnal polyuria. 8. The method of claim 1, wherein the dose of desmopressin free base is supplied in the form of the acetate salt of desmopressin. 9. A method for reducing nocturnal urine volume in a female 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 of 10 μg or 25 μg, 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 female 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. 10. The method of claim 9, wherein the reduction is about 179 mL for an orodispersible dose of desmopressin of 10 μg. 11. The method of claim 9, wherein the reduction is about 298 mL for an orodispersible dose of desmopressin of 25 μg. 12. The method of claim 9, wherein the patient has nocturia or nocturnal polyuria. 13. The method of claim 9, wherein the dose of desmopressin free base is supplied in the form of the acetate salt of desmopressin. 14. A method for improving a reduction in 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 μg, 50 μg, and 100 μg, wherein the dose is measured as the free base of desmopressin and the dose taken over a minimum treatment period reduces the patient's nocturnal voids compared to before administration and improves the reduction in nocturnal voids over the duration of the minimum treatment period. 15. The method of claim 14, wherein the patient has nocturia or nocturnal polyuria. 16. The method of claim 14, wherein the dose of desmopressin free base is supplied in the form of the acetate salt of desmopressin. 17. The method of claim 14, wherein the orodispersible dose is taken from 0.8 to 3 hours prior to bedtime. 18. The method of claim 14, wherein the orodispersible dose is taken once daily. 19. The method of claim 14, wherein the orodispersible dose of desmopressin is a dosage form comprising desmopressin acetate, gelatin, mannitol, and citric acid.