Claims for Patent: 7,405,203

Summary for Patent: 7,405,203

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 H. (New Canaan, CT)
Assignee:	Reprise Biopharmaceutics, LLC (New City, NY)
Application Number:	11/744,615
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,405,203
Patent Claims:	1. A method of treating nocturia, primary nocturnal enuresis, or incontinence, or for inducing voiding postponement, said method comprising administering to a patient in need thereof a pharmaceutical composition comprising a dose of desmopressin sufficient to achieve a maximum desmopressin plasma/serum concentration no greater than 10 pg/ml and maintaining the concentration within the range of about 0.5 pg/ml and 10 pg/ml for about four to six hours. 2. The method of claim 1, comprising administering said composition by transmucosal, transdermal, or intradermal delivery. 3. The method of claim 1, comprising treating nocturia. 4. The method of claim 1, comprising administering said composition by intravenous delivery. 5. The method of claim 1, comprising administering said composition by subcutaneous delivery. 6. The method of claim 1, comprising administering said composition by transmucosal delivery. 7. The method of claim 1, comprising administering said composition by transdermal delivery. 8. The method of claim 1, comprising administering said composition by intradermal delivery. 9. The method of claim 1, wherein the desmopressin plasma/serum concentration is maintained at a level no greater than about 5 pg/ml. 10. A method for inducing an antidiuretic effect in a patient comprising the step of administering to a patient a pharmaceutical composition comprising desmopressin by transmucosal, transdermal, or intradermal delivery in an amount and for a time sufficient to establish a maximum serum/plasma desmopressin concentration no greater than 10 pg/ml. 11. The method of claim 10, wherein said patient is suffering from incontinence, primary nocturnal enuresis (PNE), or nocturia. 12. The method of claim 10, wherein said desmopressin pharmaceutical composition is administered in an amount and for a time sufficient to establish a serum/plasma desmopressin concentration no greater than about 5 pg/ml. 13. A method for treating a patient suffering from nocturia comprising administering to a patient a pharmaceutical composition comprising desmopressin by transmucosal, transdermal, or intradermal delivery in an amount and for a time sufficient to establish a maximum serum/plasma desmopressin concentration greater than 0.1 pg/ml and less than 10 pg/ml. 14. The method of claim 10, wherein the patient is a human or other mammalian subject. 15. The method of claim 13, wherein said concentration is maintained greater than 0.1 pg/ml for a time greater than 4 hours.