Salix Pharmaceuticals receives FDA approval for Xifaxan 550 mg to treat IBS-D in adults

In continuation of my update on xifaxan

Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced that its wholly owned subsidiary, Salix Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for Xifaxan® 550 mg for the treatment of IBS-D in adults. The FDA approval of Xifaxan 550 mg is based on data from three phase 3 studies, TARGET 1, TARGET 2 and TARGET 3. Xifaxan 550 mg was studied in over 3,000 patients and demonstrated the efficacy and safety of repeat treatment following completion of a two-week course of treatment. A full course of Xifaxan 550 mg for IBS-D is available in a convenient 2 week pack of 42 pills.

"As a gastroenterologist who helps patients navigate the symptoms of IBS-D, I see the need for treatments that directly address those most bothersome, such as diarrhea and abdominal pain" said Dr. Mark Pimentel, director of the Gastrointestinal Motility Program and Laboratory at Cedars-Sinai in Los Angeles. "Today's approval gives a new option to these patients and providers."

Salix Pharmaceuticals receives FDA approval for Xifaxan 550 mg to treat IBS-D in adults

Rifaximin for Irritable Bowel Syndrome.....

Rifaximin is a semisynthetic, rifamycin-based non-systemic orally  administered antibiotic drug. It is used in the treatment of traveler's diarrhea and hepatic encephalopathy, for which it received orphan drug status from the U.S. Food and Drug Administration in 1998.

Now Cedars-Sinai researchers, have come up with an interesting finding, i.e., rifaximin (see structure)  is the first drug treatment for IBS that relieves symptoms while it's being administered and continues to benefit patients after they stop taking the drug. 

Researchers lead by Dr. Mark Pimentel found that patients who took rifaximin not only experienced relief of their IBS symptoms, including specific symptoms of bloating, abdominal pain and stool consistency, while they were taking the antibiotic, but also that their relief was sustained over the 10 week follow-up period when no antibiotic was administered.

The results of the studies were presented at the Digestive Disease Week conference in New Orleans on 3rd May.

"These studies validate the role of altered gut bacteria in IBS," said  Dr. Mark Pimentel,  GI Motility Program director at Cedars-Sinai and the principal investigator of the clinical trail at Cedars. "These findings show that targeted antibiotics provide safe and long-lasting improvement for IBS patients."........

Ref : http://www.cedars-sinai.edu/About-Us/News/Past-Issue-Documents/IBSPimentelACG.pdf