BioCentury
ARTICLE | Clinical News

Xifaxan rifaximin: Phase III started

February 27, 2012 8:00 AM UTC

Salix began the U.S. Phase III Target 3 trial to evaluate retreatment with 550 mg oral Xifaxan given thrice daily for 2 weeks in about 800 patients with IBS-D. Following a run-in period with placebo, patients will receive open-label Xifaxan treatment for 2 weeks. Patients who respond to initial treatment and then experience recurrence will be randomized to receive Xifaxan or placebo for 2 weeks in the double-blind portion of the trial. The trial includes a second, 6-week retreatment phase after a 4-week treatment-free follow-up period.

In November, FDA's Gastrointestinal Drugs Advisory Committee backed the design of the retreatment trial and said it was acceptable to address short-term treatment of symptomatic recurrence (see BioCentury, Nov. 21, 2011).The panel also voted that the company should study dose levels and regimens in addition to the 14-day regimen of 550 mg thrice daily proposed by Salix. The agency asked for the retreatment trial in a March 2011 complete response letter (see BioCentury, March 14, 2011). ...