In the Phase III clinical program, Santarus plans to undertake two international multicenter, randomized, double-blind studies, each with up to approximately 300 patients, to assess the efficacy and safety of rifamycin SV MMX 400 mg (2 times 200 mg) oral tablets taken twice daily (800 mg total daily dose) for three days versus placebo in the treatment of patients with travelers' diarrhea. The primary endpoint of the Phase III clinical studies will be the time to last unformed stool (TLUS) and the studies will seek to demonstrate the superiority of rifamycin SV MMX to placebo.

Rifamycin SV MMX is a broad spectrum, semi-synthetic antibiotic with negligible systemic absorption, which is being developed for the treatment of patients with travelers' diarrhea and potentially for other diseases that have an infectious component in the colon. Due to the negligible systemic absorption of rifamycin SV, the company believes that rifamycin SV MMX will offer an opportunity for limited side effects and will be less prone to the development of antibiotic-resistant strains of bacteria, a major concern with systemically delivered antibiotics.

SOURCE Santarus, Inc.