IP Library Patent Application 12376168
Patent Application
App. No. 12/376,168

METHODS OF TREATMENT FOR ULCERATIVE COLITIS USING AMINOSALICYLATE

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Patent No.
US None
App. No.
12/376,168
Abstract

Disclosed herein is a new treatment for ulcerative colitis in male mammalian subjects. Further disclosed are increased dosages of an aminosalicylate composition for treatment of moderate ulcerative colitis in male mammalian subjects.

Claims (30)

1 . A method of treating moderate ulcerative colitis in a mammalian male subject comprising the step of administering to said mammalian male subject an aminosalicylate in an amount to deliver greater than about 2.4 g/day of 5-aminosalicylic acid to said subject.

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

3 . The method of claim 2 , comprising the step of orally administering to said mammalian male subject an aminosalicylate in an amount to deliver greater than about 2.4 g/day but less than or equal to about 4.8 g/day of 5-aminosalicylic acid to said subject.

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

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

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

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

8 . The method of claim 3 , wherein said aminosalicylate comprises mesalamine and further wherein said mesalamine is administered in an amount of about 4.8 g/day.

9 . The method of claim 3 , wherein said mammalian male subject is less than 65 years of age.

10 . The method of claim 3 , wherein said mammalian male subject is a non-smoking subject.

11 . The method of claim 3 , wherein said mammalian male subject is Caucasian.

12 . The method of claim 3 , wherein said mammalian male subject is a previous or current steroid user.

13 . The method of claim 3 , wherein said step of orally administering comprises orally administering a tablet comprising about 800 milligrams of mesalamine or a salt thereof.

14 . The method of claim 13 , wherein said tablet is a delayed-release tablet.

15 . The method of claim 3 , 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 mixtures thereof.

16 . 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.

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

18 . The method of claim 17 , 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.

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

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

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

22 . The method of claim 17 , wherein said mammalian male subject is less than 65 years of age.

23 . The method of claim 17 , wherein said mammalian male subject is a non-smoking subject.

24 . The method of claim 17 , wherein said mammalian male subject is Caucasian.

25 . The method of claim 17 , wherein said mammalian male subject is a previous or current steroid user.

26 . The method of claim 17 , 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.

27 . The method of claim 17 , wherein said rectal composition is an enema.

28 . The method of claim 17 , wherein said rectal composition is a foam.

29 . The method of claim 17 , wherein said aminosalicylate comprises a component selected from the group consisting of mesalamine, a salt of mesalamine, olsalazine, a salt of olsalazine, balsalazide, a salt of balsalazide, sulfasalazine, a salt of sulfasalazine, or any pharmaceutically acceptable combination thereof.

30 . The method of claim 29 , wherein said step of administering comprises administering once per day, twice per day, three times per day, or four times per day.

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 023121/0544 →