Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced positive
top-line results from an open-label phase 3 clinical trial designed to
evaluate the long-term safety and efficacy of lubiprostone in
opioid-induced bowel dysfunction (OBD) patients with chronic,
In this open-label study (439 subjects treated) of 36 weeks' duration
there were no reported serious adverse events that were considered
drug-related. The most common adverse events (greater than 5%) that
arose during the trial were diarrhea (9.6%), nausea (8.9%), upper
respiratory infection (6.4%) and back pain (5.2%). The most common
adverse events that were considered treatment-related (greater than 2%)
were nausea (5.0%) and diarrhea (4.6%). Adverse events were categorized
in the study as mild, moderate or severe. Severe events of nausea and
diarrhea each occurred in 0.5% of patients. Overall, only 3.4% and 5.2%
of patients withdrew from the trial due to lack of efficacy or adverse
events, respectively, over the 9-month treatment period. Additionally,
treatment with lubiprostone demonstrated consistent improvements over
baseline with respect to bowel frequency rates and other OBD-related
symptoms at each timepoint measured throughout the study.
"We are highly pleased with the long term safety profile and efficacy
observed in this phase 3 trial of lubiprostone in OBD," said Ryuji Ueno,
M.D., Ph.D., Ph.D., Chair, CEO and CSO of Sucampo. "These data will be
an important part of our supplemental new drug application (sNDA). With
these data and those of the previously completed phase 3 trials, we now
have all the necessary data for submission and are preparing to file the
sNDA mid-year with a request for priority review."
Detailed results from this open-label phase 3 trial will be submitted
for presentation at an appropriate medical meeting and for publication
in an appropriate peer-reviewed journal.
Sucampo Pharmaceuticals, Inc.