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Last Updated: March 29, 2024

Details for Patent: 9,855,254


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Title:Methods of treating hepatic encephalopathy
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.
Inventor(s): Forbes; William (Raleigh, NC), Merchant; Kunal (Durham, NC), Bortey; Enoch (Chapel Hill, NC), Shaw; Audrey (Durham, NC)
Assignee: Salix Pharmaceuticals, Ltd. (Bridgewater, NJ)
Filing Date:Jul 18, 2016
Application Number:15/212,720
Claims:1. A method of reducing the risk of hospitalization for a subject having hepatic encephalopathy (HE) comprising orally administering between about 1000 mg to about 1200 mg rifaximin daily to the subject for a period of 12 months or longer, thereby reducing the risk of hospitalization.

2. The method of claim 1, wherein the amount of rifaximin is sufficient to reduce the frequency of hospitalization visits by at least 50 percent compared to a subject who is not being administered rifaximin.

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

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

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

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

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

8. The method of claim 1, wherein the subject is at least 18 years old.

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

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

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

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

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

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