Methods of treating hepatic encephalopathy

• US 9,421,195 B2
• Filed: 06/10/2013
• Issued: 08/23/2016
• 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 D
• Application Number:
  US13/914,074
• Publication Number:
  US 20130345166A1
• Time in Patent Office: 1,170 Days
• Field of Search: None
• US Class Current: 1/1
• 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 reducing the risk of hepatic encephalopathy (HE) recurrence in an adult subject in need thereof comprising:

orally administering between about 1000 mg to about 1200 mg of rifaximin daily to the adult subject for a period of 12 months or longer, thereby reducing the risk of hepatic encephalopathy (HE) recurrence.

2. The method of claim 1, wherein the HE is overt hepatic encephalopathy.

3. The method of claim 1, wherein the adult subject has a history of recurrent, episodic, and overt hepatic encephalopathy (HE).

4. The method of claim 1, further comprising administering lactulose to the adult subject.

5. The method of claim 1 comprising orally administering about 1100 mg of rifaximin per day to the adult subject.

6. The method of claim 5 comprising orally administering about 550 mg of rifaximin twice daily to the adult subject.

7. The method of claim 1, wherein the adult subject is at least 21 years old.

8. The method of claim 1, wherein the rifaximin is administered to the adult subject with or without food.

9. The method of claim 1 comprising administering the rifaximin to the adult subject for a duration between 12 to 24 months.

10. The method of claim 1 comprising administering the rifaximin to the adult subject for the duration of the subject'"'"'s life.

11. The method of claim 1, wherein the adult subject has had two or fewer HE episodes in the 6-month period prior to commencing administration of rifaximin.

12. The method of claim 1, wherein the adult subject has had two or more HE episodes in the 6-month period prior to commencing administration of rifaximin.