Claims for Patent: 9,421,195

Summary for Patent: 9,421,195

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:	13/914,074
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,421,195
Patent 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.