Santarus, Inc. (NASDAQ: SNTS) today announced 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 (TLUS) in patients with
travelers' diarrhea.
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. Results in the per protocol population (n=240) were similar to the ITT population.
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 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. Santarus
expects additional data from this clinical study will be presented at an
appropriate medical meeting in 2013.