Salix starts three late-stage trials of treatments for gastrointestinal disease

By Lisa Kerner

Erie, Pa., Jan. 11 - Salix Pharmaceuticals, Ltd. provided an update on several trials evaluating its products to treat gastrointestinal diseases. Initial subjects have been enrolled and dosed in three late-stage trials, according to a company news release.

Xifaxan (rifaximin), dosed 400 mg three times daily, is being investigated in a vancomycin comparator, 300-subject phase 3 trial to evaluate the efficacy and safety of Xifaxan for the treatment of C. difficile-Associated Diarrhea (CDAD) The presence of clostridium difficile, or C. difficile, can produce symptoms ranging from mild diarrhea to life-threatening colitis.

Xifaxan, dosed either 275 mg, 550 mg or 1,100 mg twice daily, is being investigated in a placebo-controlled, 525-subject phase 2b trial to evaluate Xifaxan for the treatment of diarrhea-associated Irritable Bowel Syndrome. The syndrome is characterized by altered bowel function and symptoms including abdominal pain, bloating, constipation and diarrhea. Irritable Bowel Syndrome impacts to 20% of the U.S. population. An overgrowth of bacteria in the small intestine has been proposed as a causative agent.

Xifaxan, dosed 550 mg twice daily, is being investigated in a placebo-controlled, 250-subject phase 3 trial to evaluate Xifaxan for the prevention of Hepatic Encephalopathy, a metabolic-neurophysiologic syndrome associated with advanced liver disease. Neuropsychiatric and neuromuscular symptoms range from mild personality changes, memory loss, and tremor to coma and death.

Colazal (balsalazide disodium), formulated as an 1,100 mg tablet, dosed three tablets twice daily, is being investigated in a multi-center, placebo-controlled, double-blind, randomized trial. The phase 3 trial, involving 225 patients, is designed to evaluate 1100 mg tablets for the treatment of mildly to moderately active ulcerative colitis.

Granulated mesalamine is being investigated in two 300-subject, multi-center, placebo-controlled, double-blind, randomized trials. Enrollment is ongoing in these phase 3 trials to evaluate the efficacy and safety of granulated mesalamine, dosed four 375 mg tablets once daily, for the maintenance of remission of ulcerative colitis.

A pediatric trial with Colazal is currently ongoing. Enrollment in the trial is anticipated to be complete during the first quarter of 2006. A trial with Xifaxan to assess blood concentrations of a new pediatric suspension is also planned for this year.

New Drug Applications for INKP-102, the next-generation tablet purgative product owned by subsidiary, InKine; and NRL944, the liquid PEG purgative product acquired from Norgine, are under review at the U.S. Food and Drug Administration.

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

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