News Feature | February 13, 2014

Salix Pharmaceuticals Issued Patent For Rifaximin Tablets

Source: Clinical Leader

By Cyndi Root

Salix Pharmaceuticals, Ltd. announced in a press release that it received a U.S. patent for its treatment method in hepatic encephalopathy (HE). The United States Patent and Trademark Office issued Patent No. 8,642,573 for “Methods of Treating Hepatic Encephalopathy,” good until October 2029. The patent provides intellectual property protection. The company views patent protection as essential to manage the life cycle of the XIFAXAN (rifaximin) 550 mg tablet. Salix has 13 Orange Book listings, five of which have method of treatment innovations.   

Carolyn Logan, President and Chief Executive Officer of Salix, said, “We are pleased with the issuance of this patent that protects rifaximin for our hepatic encephalopathy indication. Currently, Xifaxan 550 accounts for more than 95% of our total Xifaxan business.” She added that the patent protection extended to the specific treatment indication, the manufacturing method, and the pharmaceutical composition of Xifaxan 550.

Hepatic Encephalopathy

Hepatic encephalopathy (HE) is a brain condition that results from liver disease. When the liver cannot remove toxins or make them harmless, poisons build in the bloodstream. These toxins like ammonia damage the nervous system. Conditions like hepatitis and cirrhosis commonly cause hepatic encephalopathy. The condition can arise suddenly and be treated successfully, or it can reoccur and get worse. Symptoms include mental confusion, mood changes, sleep disorders, and sweet smelling breath in mild cases. In more severe cases, people can have seizures, become unconscious, and enter a coma.

Xifaxan 550

Xifaxan 500 mg (rifamycin) is an antibacterial designed to stop HE from reoccurring or to maintain remission. Like all antibiotics, Xifaxan changes the gastrointestinal environment, especially the colon. Bacteria overgrowth can occur including proliferation of Clostridium difficile (C. difficile) bacteria. Patients can experience mild diarrhea or fatal colitis when using the drug. Other side effects include nausea, fatigue, dizziness, fluid in the stomach, and swelling in the lower limbs. Animal studies show danger to developing fetuses.

About Salix

Salix Pharmaceuticals, Ltd. is located in Raleigh, North Carolina. It is a pharmaceutical company focused on developing and marketing drugs for gastrointestinal diseases. The company pursues a strategy of licensing late-stage drugs and marketing proprietary products. Salix pursues regulatory approvals and offers products through its marketing group.

Source:

http://www.salix.com/news-media/news/index/salix-pharmaceuticals-announces-issuance-of-u.s.-patent-for-rifaximin