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Sep 12, 2012

Travelers’ Diarrhea Drug Success in First Phase III Study

  • Santarus reported positive data from a Phase III study evaluating rifamycin SV MMX® in the treatment of travellers’ diarrhea. The primary endpoint in the 264-patient placebo-controlled trial was a reduction in time to last uniformed stool (TLUS). Results showed that in the intent-to-treat population median TLUS was 46 hours for patients in the rifamycin SV MMX cohort, compared with 68 hours in the placebo group. Results in the per protocol population were similar to those in the intent-to-treat population.

    Santarus is developing and rifamycin SV MMX in the U.S. under license from Cosmo Technologies. Cosmo’s European development partner for the drug, Dr. Falk Pharma, is carrying out a second, 1000 patient Phase III noninferiority study comparing the efficacy of rifamycin SV MMX with ciprofloxacin. Trial completion is expected in mid-2013. If the results of this study are positive Santarus and Dr. Falk plan to share and include clinical data from each others’ Phase III studies in their respective regulatory submissions.

    “Rifamycin SV is an investigational broad-spectrum, nonsystemic antibiotic that has been used for more than 20 years in Europe in both intravenous and intramuscular forms, but is considered a new chemical entity in the U.S.," explains Wendell Wierenga, Ph.D., executive vp for R&D at Santarus. “As we wait for completion of the second ongoing Phase III study being conducted by Dr. Falk Pharma, we plant to assess our options to evaluate rifamycin SV MMX in other indications where a nonsystemic antibiotic with a broad spectrum activity may offer a clinical benefit."

    Rifamycin SV MMX has been developed using Cosmo’s controlled-release Multi Matrix (MMX) technology, which is designed to delay absorption of a drug until it reaches the lumen of the colon.

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