IP Library Patent Application 12309930
Patent Application
App. No. 12/309,930

METHODS OF TREATMENT FOR ULCERATIVE COLITIS

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Quick Facts
Patent No.
US None
App. No.
12/309,930
Abstract

Disclosed herein are new treatments for moderate ulcerative colitis in various subject subgroups. The various subject subgroups include Caucasians, non-smokers, subjects under the age of about 65 years, and subjects previously or currently being treated with steroids.

Claims (34)

1 . A method of treating moderate ulcerative colitis in a mammalian subject comprising he step of administering to said mammalian subject an aminosalicylate in an amount to deliver to said subject more than about 2.4 g/day of 5-aminosalicylic acid, wherein said mammalian subject is selected from the group consisting of:

human subjects under about 65 years of age,

Caucasian human subjects,

non-smoking human subjects; and,

previous or current steroid-using mammalian subjects.

2 . The method of claim 1 , wherein the mammalian subject is a human.

3 . The method of claim 2 , wherein said step of administering an aminosalicylate comprises orally administering an aminosalicylate in an amount to deliver less than about 4.8 g/day of 5-aminosalicylic acid to said subject.

4 . The method of claim 3 , wherein said aminosalicylate comprises mesalamine or a salt thereof.

5 . The method of claim 3 , wherein said step of orally administering comprises orally administering once per day, twice per day, three times per day, or four times per day.

6 . The method of claim 2 , wherein said aminosalicylate comprises mesalamine or a salt thereof.

7 . The method of claim 6 , wherein said aminosalicylate comprises mesalamine and further wherein said mesalamine is administered in an amount of about 4.8 g/day.

8 . The method of claim 2 , wherein said step of orally administering comprises orally administering a tablet comprising about 800 milligrams of mesalamine or a salt thereof.

9 . The method of claim 8 , wherein said tablet is a delayed-release tablet.

10 . The method of claim 2 , wherein said aminosalicylate comprises a component selected from the group consisting of mesalmine, salts of mesalamine, olsalazine, salts of olsalazine, balsalazide, salts of balsalazide, sulfasalazine, salts of sulfasalazine, and combinations thereof.

11 . The method of claim 2 , wherein said step of orally administering comprises orally administering once per day, twice per day, three times per day, or four times per day.

12 . The method of claim 2 , wherein the human subject is under about 65 years of age.

13 . The method of claim 2 , wherein the human subject is Caucasian.

14 . The method of claim 2 , wherein the human subject is a non-smoking human subject.

15 . The method of claim 2 , wherein the human subject is a previous or current steroid user.

16 . The method of claim 2 , wherein the step of administering comprises rectal administration.

17 . The method of claim 16 , wherein said step of administering an aminosalicylate comprises administering an aminosalicylate in an amount to deliver about 4.8 g/day of 5-aminosalicylic acid to said subject.

18 . The method of claim 17 , wherein said aminosalicylate comprises mesalamine or a salt thereof.

19 . The method of claim 18 , wherein said step of administering comprises administering once per day, twice per day, three times per day, or four times per day.

20 . The method of claim 16 , wherein said aminosalicylate comprises mesalamine or a salt thereof.

21 . The method of claim 16 , wherein said aminosalicylate comprises mesalamine and further wherein said mesalamine is administered in an amount of about 4.8 g/day.

22 . The method of claim 16 , wherein said step of administering comprises administering a rectal composition comprising about 800 milligrams or about 1.2 g of mesalamine or a salt thereof.

23 . The method of claim 16 , wherein said rectal composition is an enema.

24 . The method of claim 16 , wherein said rectal composition is a foam.

25 . The method of claim 16 , wherein said aminosalicylate comprises a component selected from the group consisting of mesalamine, salts of mesalamine, olsalazine, salts of olsalazine, balsalazide, salts of balsalazide, sulfasalazine, salts of sulfasalazine, and combinations thereof.

26 . The method of claim 16 , wherein said step of administering comprises administering once per day, twice per day, three times per day, or four times per day.

27 . The method of claim 16 , wherein the human subject is under about 65 years of age.

28 . The method of claim 16 , wherein the human subject is Caucasian.

29 . The method of claim 16 , wherein the human subject is a non-smoking human subject.

30 . The method of claim 16 , wherein the human subject is a previous or current steroid user.

Assignments (6)
RELEASE OF SECURITY INTEREST Recorded Oct 31, 2013
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: WARNER CHILCOTT COMPANY, LLC
Reel/Frame 031531/0538 →
SECURITY AGREEMENT Recorded Mar 30, 2011
From: WARNER CHILCOTT COMPANY LLC
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 026064/0607 →
RELEASE - REEL 023456, FRAME 0052 Recorded Mar 29, 2011
From: CREDIT SUISSSE AG, CAYMAN ISLANDS BRANCH, AS ADMINISTRATIVE AGENT
To: WARNER CHILCOTT COMPANY LLC
Reel/Frame 026042/0046 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 8, 2010
From: PROCTER & GAMBLE COMPANY, THE
To: WARNER CHILCOTT COMPANY, LLC
Reel/Frame 023796/0417 →
SECURITY AGREEMENT Recorded Nov 2, 2009
From: WARNER CHILCOTT COMPANY, LLC
To: CREDIT SUISSE, CAYMAN ISLANDS BRANCH, AS ADMINISTRATIVE AGENT
Reel/Frame 023456/0052 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 20, 2009
From: YEH, CHYON-HWA; LAW, LINDA MARY; REGALLI, GINO; ZORICH, NORA LEE; MEYER, JOAN MARIE; SCHOFIELD, PAMELA JEAN
To: THE PROCTER & GAMBLE COMPANY
Reel/Frame 023121/0452 →