Salix says Xifaxan provides relief for irritable bowel syndrome; other drug data released

By Elaine Rigoli

Tampa, Fla., May 22 - Salix Pharmaceuticals, Ltd. announced the results of one investigator-initiated trial of Xifaxan (rifaximin) tablets 200 mg, suggesting that Xifaxan provides durable improvement in symptom relief for irritable bowel syndrome patients.

This durability of improvement that follows the completion of a 10-day course of Xifaxan is a marked differentiating factor between Xifaxan therapy and current therapies, which require continuous and chronic treatment, the company said in a news release.

The company also released data from one investigator-initiated trial of Colazal (balsalazide disodium) capsules 750 mg, showing that Colazal is able to deliver 99% of its active ingredient, 5-ASA, to the colon, a potential remedy for diseases such as colitis.

In other research news, Xifaxan was also shown effective for travelers' diarrhea and hepatic encephalopathy (HE). In the travelers' diarrhea study, researchers compared the efficacy of the combination of the antibiotic rifaximin and the antimotility agent loperamide with that of each agent administered alone.

A total of 319 U.S. subjects, studying in Mexico with acute diarrhea, were randomized in a double-blind study to receive one of three drug regimens: rifaximin 200 mg TID; loperamide 4 mg initially followed by 2 mg after each unformed stool; or both drugs in the same dosage schedule for three days.

Subjects completed a diary each day for five days. Over the five-day period, the median time from first dose of drug until passage of last unformed stool was shorter for both rifaximin-containing regimens, the release said.

In the HE trial, researchers investigated the efficacy and tolerability of rifaximin for the treatment of stage 1 hepatic encephalopathy in patients with cirrhosis due to hepatitis C virus (HCV). A total of 37 outpatients were treated with rifaximin 400 mg TID for 14 days.

Patients were assessed 24 hours prior to the start of therapy and 14 days after completion of therapy for multiple parameters, including ability to perform mental tasks, asterixis and a quality-of-life composite score.

Twenty-three patients were receiving pegylated interferon plus ribavirin for chronic HCV and 17 of these patients also were receiving a selective serotonin reuptake inhibitor for mild IFN-induced depression. Type 2 diabetes mellitus was reported in 12 patients.

Rifaximin treatment lowered serum ammonia to normal levels in all patients, and overall, HE symptoms improved, the release said.

Salix, based in Raleigh, N.C., develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases.

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