52%
of patients saw relief
from abdominal pain compared to
43% placebo
76%
of patients saw relief from
diarrhea compared to
66% placebo
47%
of patients saw relief from
abdominal pain and
diarrhea compared to
37% placebo
Target 1 & 2 Study Design: Two identical, randomized, phase 3 trials conducted
over a 3-month period. A total of 1258 patients meeting Rome II criteria for IBS received XIFAXAN
550 mg 3 times a day (n=624) or placebo (n=634) for 14 days. Primary endpoint was
adequate relief of IBS signs and symptoms for at least 2 of 4 weeks during the month following 14
days of treatment. Adequate relief was defined as a response of “yes” to the weekly
Subject Global Assessment (SGA) question: “In regards to your IBS symptoms, compared to
the way you felt before you started study medication, have you, in the past 7 days, had adequate
relief of your IBS symptoms? [Yes/No].” Primary endpoint: 41% of
patients (254 of 624) in the XIFAXAN 550 mg group, 31% of TARGET 1 placebo group (98 of 314) and 32%
of TARGET 2 placebo group (103 of 320) experienced adequate relief of IBS signs and symptoms.
Composite endpoint was defined as ≥30% decrease from baseline in abdominal pain
with a weekly average stool consistency score of <4 (loose stool) for ≥2 weeks during the
month following 2 weeks of treatment.