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Last Updated: April 12, 2025

Claims for Patent: 10,335,397

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Summary for Patent: 10,335,397

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.
Inventor(s):	Forbes; William (Raleigh, NC)
Assignee:	Salix Pharmaceuticals, Ltd (Bridgewater, NJ)
Application Number:	15/922,010
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,335,397
Patent Claims:	1. A method of reducing a subject's risk of experiencing a breakthrough overt hepatic encephalopathy (HE) episode, comprising administering to the subject between about 1000 mg to about 1200 mg of rifaximin daily for a period of about 12 months or longer, wherein the subject has a Conn score of 0 or 1. 2. The method of claim 1, wherein a breakthrough overt HE episode comprises an increase in the Conn score to Grade greater than or equal to 2. 3. The method of claim 1, wherein a breakthrough overt HE episode for subjects having a Conn score of 0 comprises a Conn and Asterixis score increase of 1 grade. 4. 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. 5. The method of claim 1, wherein the subject has a Model for End-Stage Liver Disease (MELD) score of 1 to 24. 6. The method of claim 1, wherein the subject has a MELD score of less than or equal to 10. 7. The method of claim 1, wherein the subject has a MELD score of between 11 and 18. 8. The method of claim 1, wherein the subject has a MELD score of between 19 and 24. 9. The method of claim 1, wherein the rifaximin is administered orally. 10. The method of claim 9, wherein 1100 mg of rifaximin is administered per day. 11. The method of claims 10, wherein 550 mg of rifaximin is administered twice daily. 12. The method of claim 1, further comprising administering lactulose. 13. A method of reducing a subject's risk of experiencing a breakthrough overt hepatic encephalopathy (HE) episode, comprising orally administering to the subject 550 mg rifaximin twice daily for a period of about 12 months or longer, wherein the subject has a Conn score of 0 or 1, a MELD score of 1 to 24, and has had two or more overt HE episodes within 6-months prior to the administration of rifaximin.

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