According to the study data, in the intent-to-treat (ITT) population (n=264), the median TLUS was 46.0 hours for rifamycin SV MMX (n=199) compared with 68.0 hours for placebo (n=65), p = 0.0008 and results in the per protocol population (n=240) were similar to the ITT population.
Rifamycin SV MMX was generally well tolerated in the study and the frequency of treatment emergent adverse events was similar to placebo.
Santarus research and development executive vice president Wendell Wierenga said the favourable Phase III results in travelers’ diarrhoea represent a significant positive milestone in the clinical development of rifamycin SV MMX for the US market.
"Rifamycin SV is an investigational broad spectrum, non-systemic 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 US," Wierenga added.
Santarus previously signed a licensing deal with Cosmo Technologies to develop and commercialise rifamycin SV MMX in the US.
Cosmo’s European development partner, Dr. Falk Pharma is conducting a second Phase III study of rifamycin SV MMX versus ciprofloxacin with the primary endpoint of TLUS in patients with travelers’ diarrhoea. If the study yeilds positive results, Santarus and Dr. Falk plan to share the clinical data from their respective studies to include in each company’s regulatory submissions.