Claims for Patent: 7,579,321

Summary for Patent: 7,579,321

Title:	Pharmaceutical compositions including low dosages of desmopressin
Abstract:	The present invention is directed to a pharmaceutical composition comprising 0.5 ng to 20 .mu.g 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.
Inventor(s):	Fein; Seymour (New Canaan, CT)
Assignee:	Reprise Biopharmaceutics, LLC (New City, NY)
Application Number:	12/173,074
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,579,321
Patent Claims:	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 .mu.g to 2 .mu.g) 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.