Methods of treating hepatic encephalopathy

• US 8,642,573 B2
• Filed: 01/09/2013
• Issued: 02/04/2014
• Est. Priority Date: 10/02/2008
• Status: Active Grant

• Current Assignee: Salix Pharmaceuticals Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Salix Pharmaceuticals Limited (Bausch Health Cos., Inc.)
• Inventors: Forbes, William, Merchant, Kunal, Bortey, Enoch, Shaw, Audrey
• Primary Examiner(s): Ricci, Craig
• Application Number:
  US13/737,535
• Publication Number:
  US 20130123209A1
• Time in Patent Office: 391 Days
• Field of Search: None
• US Class Current: 514/53
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/437 the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
• CPC Class Codes: A61K 31/7016 Disaccharides, e.g. lactose, lactulose lactobionic acid A61K31/7032
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

The application describes treatment of hepatic encephalopathy using gastrointestinal specific antibiotics. One example of a gastrointestinal specific antibiotic is rifaximin. The instant application also provides methods for determining if a subject has a neurological condition or hepatic encephalopathy by determining the critical flicker frequency and/or the venous ammonia level of the subject at two or more time points. The invention further provides methods for treating these subjects.

Claims

1. A method of maintaining remission of hepatic encephalopathy (HE) in a subject in need thereof comprising administering between about 1000 mg to about 1200 mg rifaximin daily to the subject for a period of 12 months or longer, thereby maintaining remission of HE.

2. The method of claim 1, further comprising administering lactulose.

3. The method of claim 1, wherein the subject is identified as being in remission from HE prior to administration of rifaximin.

4. The method of claim 1, wherein rifaximin is administered to the subject for between about 12 to about 24 months.

5. The method of claim 1, wherein rifaximin is administered to the subject until death.

6. The method of claim 1, wherein the subject is administered about 1100 mg of rifaximin per day.

7. The method of claim 6, wherein 550 mg of rifaximin is administered to the subject two times per day (BID).

8. The method of claim 7, wherein remission is defined as a Conn score of 0 or 1.