IP Library Granted Patent US 7,579,321
Granted Patent B2
US 7,579,321 · App. 12/173,074 · Granted Aug 25, 2009

Pharmaceutical compositions including low dosages of desmopressin

Assignee: Reprise Biopharmaceutics, LLC
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Quick Facts
Patent No.
US 7,579,321
App. No.
12/173,074
Granted
Aug 25, 2009
Kind
B2
Abstract

The present invention is directed to a pharmaceutical composition comprising 0.5 ng to 20 μg desmopressin and a pharmaceutically acceptable carrier. The present invention is also directed to a pharmaceutical composition comprising desmopressin and a pharmaceutically acceptable carrier, wherein the pharmaceutical composition is effective to establish a steady plasma/serum desmopressin concentration in the range of from about 0.1 picograms desmopressin per mL plasma/serum to about 10.0 picogram desmopressin per mL plasma/serum. Articles of manufacture and methods of using the above invention are also disclosed.

Claims (21)

1. A method for inducing voiding postponement in a patient while reducing the risk that the patient develops hyponatremia comprising delivering to the bloodstream of the patient an amount of desmopressin no more than about 2 ng/kg by intranasal, transdermal, intradermal, transmucosal, or conjunctival administration, said amount being therapeutically effective to produce an antidiuretic effect lasting for no more than between about 4 and about 6 hours.

2. The method of claim 1 comprising delivering to the bloodstream of the patient an amount of desmopressin no more than about 1 ng/kg.

3. The method of claim 1 further comprising advising a patient that fluid intake should be restricted after administration.

4. The method of claim 1 further comprising advising the patient that no water should be taken after administration.

5. The method of claim 1 comprising administering desmopressin to a patient suffering from nocturia, primary nocturnal enuresis (PNE), or incontinence.

6. The method of claim 1 wherein the method produces a plasma/serum desmopressin concentration in the patient of a maximum of no more than about 10 pg/ml.

7. The method of claim 1 wherein the method produces a plasma/serum desmopressin concentration in the patient of a maximum of no more than about 5 pg/ml.

8. A method for inducing voiding postponement comprising administering to a patient an amount of desmopressin sufficient to produce in the patient a urine osmolality ranging above about 300 mOsm/kg for less than about 5 hours after administration.

9. The method of claim 1 or 8 comprising administering the desmopressin by intranasal administration.

10. The method of claim 1 or 8 comprising administering the desmopressin by transdermal administration.

11. The method of claim 1 or 8 comprising administering the desmopressin by intradermal administration.

12. The method of claim 1 or 8 comprising administering the desmopressin by transmucosal administration.

13. The method of claim 1 or 8 comprising administering the desmopressin by conjunctival administration.

14. The method of claim 1 or 8 comprising administering to the patient between 100 and 2000 ng (0.1 μg to 2 μg) desmopressin.

15. The method of claim 8 wherein the method produces a plasma/serum desmopressin concentration in the patient no more than about 10 pg/ml.

16. The method of claim 8 wherein the method produces a plasma/serum desmopressin concentration in the patient no more than about 5 pg/ml.

17. The method of claim 8 comprising delivering to the bloodstream of the patient no more than about 2 ng/kg desmopressin.

18. The method of claim 8 comprising delivering desmopressin to the bloodstream of a patient suffering from nocturia, PNE, or incontinence.

19. A method for inducing voiding postponement in a patient while reducing the risk that the patient develops hyponatremia comprising delivering to the bloodstream of the patient via transdermal, intradermal, transmucosal, or conjunctival administration no more than about 1 ng/kg desmopressin to produce an antidiuretic effect for no more than about four to about six hours.

20. A method for inducing voiding postponement in a patient while reducing the risk that the patient develops hyponatremia comprising delivering to the bloodstream of the patient via intranasal administration no more than about 2 ng/kg of desmopressin so as to produce an antidiuretic effect.

21. The method of claim 20 comprising delivering to the bloodstream of the patient no more than about 1 ng/kg desmopressin.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 29, 2021
From: REPRISE BIOPHARMACEUTICS, LLC
To: SERENITY PHARMACEUTICALS LLC
Reel/Frame 058499/0653 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE AND ASSIGNMENT DOCUMENT PREVIOUSLY RECORDED ON REEL 042747 FRAME 0283. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Jun 20, 2017
From: ALLERGAN, INC.
To: REPRISE BIOPHARMACEUTICS, LLC
Reel/Frame 042917/0184 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 19, 2017
From: ALLERGAN, INC.
To: SERENITY PHARMACEUTICALS LLC
Reel/Frame 042747/0283 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 19, 2010
From: REPRISE BIOPHARMACEUTICS, LLC
To: ALLERGAN, INC.
Reel/Frame 024412/0072 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE'S CITY ADDRESS PREVIOUSLY RECORDED ON REEL 022954 FRAME 0040. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT AGREEMENT. Recorded Aug 21, 2009
From: FEIN, SEYMOUR
To: REPRISE BIOPHARMACEUTICS LLC
Reel/Frame 023128/0258 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 14, 2009
From: FEIN, SEYMOUR
To: REPRISE BIOPHARMACEUTICS, LLC
Reel/Frame 022954/0040 →
Priority Claims (1)
GB 0210397.6 · May 7, 2002 · national
Continuity (4)
Continuation 1174461500 · May 4, 2007
Division 1070610000 · Nov 12, 2003
Continuation In Part PCTUS031446300 · May 6, 2003
Related Publication 20090005432A1 · Jan 1, 2009