IP Library Patent Application 16893651
Patent Application
App. No. 16/893,651

METHODS OF TREATING HEPATIC ENCEPHALOPATHY

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Quick Facts
Patent No.
US None
App. No.
16/893,651
Abstract

The application describes treatment of hepatic encephalopathy using gastrointestinal specific antibiotics. One example of a gastrointestinal specific antibiotic is rifaximin.

Claims (35)

1 . (canceled)

2 . (canceled)

3 . A method of decreasing a subject's risk of a hepatic encephalopathy (HE) breakthrough episode comprising administering rifaximin to a subject suffering from HE.

4 . The method of claim 3 , wherein the risk of the episode for subjects having a last HE episode equal to, or greater than, 90 days prior to the administration is reduced by about 58% or between about 30% to 70% or between about 40% to about 70%.

5 . (canceled)

6 . The method of claim 3 , wherein the risk of the episode for subjects having a last HE episode greater than 90 days prior to the administration is decreased by between about 60% or between about 2% to 80%.

7 . (canceled)

8 . The method of claim 3 , wherein the risk of the episode for subjects having two or fewer HE episodes in the six months prior to the administration is reduced by about 56% or between about 20% to 70%.

9 . (canceled)

10 . The method of claim 3 , wherein the risk of the episode for subjects having greater than two HE episodes in the six months prior to rifaximin administration is reduced by about 63% or between about 30% to about 80%.

11 - 13 . (canceled)

14 . A method of maintaining remission of HE in a subject comprising administering rifaximin to a subject suffering from HE.

15 . A method of reducing the frequency of hospitalization visits by an HE patient, comprising administering rifaximin to a subject suffering from HE.

16 . The method of claim 15 , wherein administration of rifaximin reduces hospitalization frequency by about 48% or from between about 13% to about 69%.

17 - 19 . (canceled)

20 . The method of claim 15 [[ 19 ]], wherein 550 mg of rifaximin is administered to the subject two times per day (BID) or 275 mg of rifaximin is administered to the subject four times per day or 275 mg of rifaximin is administered to the subject as two dosage forms two times per day.

21 . (canceled)

22 . (canceled)

23 . The method of claim 3 , wherein the GI specific antibiotic is administered to the subject for six months, one year, two to three years, or until the subject's death.

24 - 26 . (canceled)

27 . The method of claim 3 , wherein a Conn score or the quality of life (QoL) measurement of the subject is improved over baseline following administration of rifaximin.

28 . (canceled)

29 . The method of claim 3 , further comprising administering one or more of align, alinia, lactulose, pentasa, cholestyramine, sandostatin, vancomycin, lactose, amitiza, flagyl, zegerid, prevacid, or miralax.

30 - 37 . (canceled)

38 . The method of claim 3 , wherein there is an increase in time to a first HE-related hospitalization of the subject, an increase in the time to development of spontaneous bacterial peritonitis (SBP) of the subject or an increase in critical flicker frequency values from baseline after administration of rifaximin to the subject.

39 . (canceled)

40 . The method of claim 3 , wherein there is a decrease in blood ammonia concentration from baseline or a decrease in daily lactulose consumption from baseline over time after administration of rifaximin to the subject.

41 - 46 . (canceled)

47 . The method of claim 3 , wherein there is a shift in baseline in Conn scores, in asterixis grades, in Chronic Liver Disease Questionnaire (CLDQ) scores or in Epworth Sleepiness Scale scores over time after administration of rifaximin to the subject.

48 - 51 . (canceled)

52 . The method of claim 3 , wherein subjects having a meld level of between about 1 to 24 respond to treatment with rifaximin.

53 - 74 . (canceled)

75 . A method of increasing the time between breakthrough events for a patient suffering from hepatic encephalopathy, comprising administering to the patient an effective amount of rifaximin that extends the time between hepatic encephalopathy breakthrough events.

76 . The method of claim 75 , wherein the time between breakthrough events for the patient is extended to greater than six months or greater than 12 months.

77 - 96 . (canceled)

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded Apr 8, 2025
From: BARCLAYS BANK PLC, AS COLLATERAL AGENT
To: SOLTA MEDICAL, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH IRELAND LIMITED (F/K/A/ VALEANT PHARMACEUTICALS IRELAND LIMITED); SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD; SANTARUS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; HUMAX PHARMACEUTICAL S.A.; SOLTA MEDICAL IRELAND LIMITED; BAUSCH & LOMB MEXICO, S.A. DE C.V.; BAUSCH+LOMB OPS B.V.; BAUSCH HEALTH AMERICAS, INC.; BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH HOLDCO LIMITED; BAUSCH HEALTH MAGYARORSZAG KFT (A/K/A BAUSCH HEALTH HUNGARY LLC); BAUSCH HEALTH POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA (F/K/A VALEANT PHARMA POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA); BAUSCH HEALTH US, LLC; BAUSCH HEALTH, CANADA INC. / SANTE BAUSCH, CANADA INC.; ICN POLFA RZESZOW SPOLKA AKCYJNA (A/K/A ICN POLFA RZESZOW S.A.); ORAPHARMA, INC.; PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA SPOLKA AKCYJNA (A/K/A PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA S.A.); SOLTA MEDICAL DUTCH HOLDINGS B.V.; V-BAC HOLDING CORP.; VRX HOLDCO LLC; 1261229 B.C. LTD.; 1530065 B.C. LTD.
Reel/Frame 070778/0199 →
SECURITY INTEREST Recorded Jan 21, 2021
From: BAUSCH HEALTH IRELAND LIMITED; SALIX PHARMACEUTICALS, INC.; BAUSCH & LOMB INCORPORATED; SOLTA MEDICAL, INC.
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 054984/0324 →
SECURITY INTEREST Recorded Jan 21, 2021
From: BAUSCH HEALTH IRELAND LIMITED; SALIX PHARMACEUTICALS, INC.; BAUSCH & LOMB INCORPORATED; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 054984/0345 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2020
From: FORBES, WILLIAM
To: SALIX PHARMACEUTICALS, LTD.
Reel/Frame 053830/0743 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2020
From: SALIX PHARMACEUTICALS, LTD.
To: SALIX PHARMACEUTICALS, INC.
Reel/Frame 053830/0873 →