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Last Updated: April 8, 2025

Claims for Patent: 10,314,828

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Summary for Patent: 10,314,828

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)
Application Number:	15/824,209
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,314,828
Patent 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 of rifaximin daily to the subject for a period of 12 months or longer, wherein the subject has a Model for End-Stage Liver Disease (MELD) score of between about 1 to 24, thereby maintaining remission of HE. 2. The method of claim 1, wherein the subject has a MELD score of less than or equal to 10. 3. The method of claim 1, wherein the subject has a MELD score of between 11 and 18. 4. The method of claim 1, wherein the subject has a MELD score of between 19 and 24. 5. The method of claim 1, wherein remission is defined as a Conn score of 0 or 1. 6. The method of claim 1, wherein the subject has had two or more overt HE episodes within 6-months prior to the administration of rifaximin. 7. The method of claim 1, wherein the rifaximin is administered orally. 8. The method of claim 7, wherein 1100 mg of rifaximin is administered per day. 9. The method of claims 8, wherein 550 mg of rifaximin is administered twice daily. 10. The method of claim 1, further comprising administering lactulose.

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