Salix plans rifaximin "complete response"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Salix expects to submit results of a 400-patient study of its pending travelers' diarrhea treatment rifaximin to FDA by November. The study, initiated in early 2002, would respond to FDA's Oct. 25 "approvable" letter requesting further data on clinical and anti-microbial efficacy. Salix claims "there is no U.S. approved oral antibiotic with [rifaximin's] potential broad-spectrum activity, lack of systemic absorption, and safety and resistance profiles." The firm projects product sales will exceed $550 mil. in the fifth year of marketing...