Claims for Patent: 8,748,481

Summary for Patent: 8,748,481

Title:	Method for treating gastrointestinal disorder
Abstract:	The present invention relates to a method for the long term treatment of gastrointestinal disorders in a human subject, which comprises administering an effective amount of a halogenated prostaglandin compound and/or its tautomer to the subject. The method induces substantially no electrolyte shifting during the term of the treatment. The compound used in the present invention can improve quality of life in the human subjects with gastrointestinal disorders, are similarly effective in treating male and female subjects, and also effective in a human subject aged even 65 years and older.
Inventor(s):	Ueno; Ryuji (Montgomery, MD)
Assignee:	Sucampo AG (Zug, CH)
Application Number:	11/216,012
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,748,481
Patent Claims:	1. A method for the long term treatment of chronic constipation in a human subject, wherein the treatment comprises administering to the subject in need thereof an effective amount of a prostaglandin compound represented by Formula (I) and/or its tautomer: ##STR00015## wherein W.sub.1 is =O; and W.sub.2 is ##STR00016## wherein R.sub.3 and R.sub.4 are hydrogen; X.sub.1 and X.sub.2 are halogen; R.sub.2 is hydrogen or alkyl; Y is a saturated or unsaturated C.sub.2-10 hydrocarbon chain; A is --COOH or its salt, ester or amide; R1 is a saturated or unsaturated, straight chain or branched chain lower hydrocarbon; the bond between C-13 and C-14 positions is double or single bond, and the steric configuration at C-15 position is R, S or a mixture thereof, wherein said prostaglandin compound is administered for over 4 weeks, wherein the treatment induces substantially no serum electrolyte shifting during the term of treatment, wherein the amount of said prostaglandin compound to be administered is in the range of about 6-48 .mu.g per day, and wherein the treatment improves quality of life of the subject. 2. The method of claim 1, wherein said prostaglandin compound is a monocyclic tautomer of formula (I). 3. The method of claim 1, wherein the amount of said prostaglandin compound to be administered is in the range of about 6-32 .mu.g per day. 4. The method of claim 1, wherein the amount of said prostaglandin compound to be administered is in the range of about 6-16 .mu.g per day. 5. The method of claim 1, wherein the amount of said prostaglandin compound to be administered is in the range of about 8-48 .mu.g per day. 6. The method of claim 1, wherein the prostaglandin compound is administered orally. 7. The method of claim 6, wherein said prostaglandin compound is administered with an oil solvent as an excipient. 8. The method of claim 7, wherein said oil solvent is a medium chain fatty acid triglyceride. 9. The method of claim 1, wherein A is --COOH; Y is (CH.sub.2).sub.6; atoms; R.sub.2 is hydrogen atom; X.sub.1 and X.sub.2 are fluorine atoms; and R.sub.1 is (CH.sub.2).sub.3CH.sub.3. 10. The method of claim 1, wherein said prostaglandin compound is administered for at least 6 months. 11. The method of claim 1, wherein said prostaglandin compound is administered for at least 1 year. 12. The method of claim 1, wherein said human subject is a male human subject. 13. The method of claim 1, wherein said human subject is a human subject aged 65 years and older. 14. The method of claim 1, wherein A is --COOH; Y is (CH.sub.2).sub.6; atoms; R.sub.2 is hydrogen atom; X.sub.1 and X.sub.2 are fluorine atoms; and R.sub.1 is CH.sub.2CH(CH.sub.3)CH.sub.2CH.sub.3. 15. The method of claim 1, wherein said human subject is aged 18 years or older. 16. The method of claim 1, wherein said prostaglandin compound is administered for at least 2 months. 17. The method of claim 1, wherein the treatment improves quality of life of the subject that is confirmed by SF-36.