Santarus Inc. (SNTS) announced Tuesday that its Phase III clinical study to evaluate the safety and efficacy of the investigational drug, rifamycin SV MMX, met the primary endpoint of reducing time to last unformed stool or TLUS in patients with travelers' diarrhea.
The company said that the Phase III clinical study enrolled 264 patients, 65 patients on placebo and 199 patients on rifamycin SV MMX, in an international multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of rifamycin SV MMX.
The dosing regimen was 400 mg (two oral tablets of 200 mg each) taken twice daily (800 mg total daily dose) of rifamycin SV MMX or placebo for three days in the treatment of patients with travelers' diarrhea.
The company said that Rifamycin SV MMX was generally well tolerated in this Phase III clinical study and the frequency of treatment emergent adverse events was similar to placebo.
The company said that the most frequent treatment emergent adverse events experienced by = 2% of patients in either treatment group were: headache (8.0% in active arm and 9.2% in the placebo arm), diarrhea (5.0% in the active arm and 9.2% in the placebo arm), infectious diarrhea (5.0% in the active arm and 7.7% in the placebo arm), constipation (3.5% in the active arm and 1.5% in the placebo arm), amoebic dysentery (0% in the active arm and 3.1% in the placebo arm) and gastrointestinal infection (0% in the active arm versus 3.1% in the placebo arm).
There were three patients who experienced serious adverse events, all of which were assessed by the investigator as not related to the study drug. One patient in the placebo group developed clostridium difficile colitis and two patients in the rifamycin SV MMX group experienced a total of three adverse events: neuroblastoma, abdominal pain and vomiting, the company said.
The company noted that it expects additional data from this clinical study will be presented at an appropriate medical meeting in 2013.
Santarus said it licensed rights to develop and commercialize rifamycin SV MMX in the U.S. from Cosmo Technologies Limited. Dr. Falk Pharma GmbH, Cosmo's European development partner, is conducting a second Phase III clinical study to evaluate the efficacy of rifamycin SV MMX versus ciprofloxacin with the primary endpoint of TLUS in patients with travelers' diarrhea. This non-inferiority study is expected to enroll approximately 1,000 patients and to be completed in mid-2013.
by RTT Staff Writer
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