Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced the
presentation of pooled data from post-hoc analyses of the two pivotal
Phase 3 studies of AMITIZA® (lubiprostone) for the treatment
of irritable bowel syndrome with constipation (IBS-C) at Digestive
Disease Week 2012 in San Diego. This analysis of patients presenting
with moderate to very severe abdominal pain and fewer than three weekly
spontaneous bowel movements (SBMs) at baseline demonstrates that AMITIZA
provides a statistically significantly higher proportion of patients
with consistent relief from IBS-C symptoms (greater than 30% improvement
from baseline in abdominal pain ratings and normalization of bowel
frequency for 9 of the 12 treatment weeks) as compared to placebo
"IBS-C can be a debilitating and painful disease with a range of
abdominal symptoms including abdominal pain, the severity of which has
been associated with altered tight junction protein expression and
distribution," commented Ryuji Ueno, M.D., Ph.D., Ph.D., Chair, CEO and
CSO of Sucampo and an author of the poster. "The data from this analysis
adds to our understanding of AMITIZA, a chloride channel activator, in
its role in the treatment of moderate to very severe IBS-C."
The poster entitled "Patient Response to Lubiprostone for the Treatment
of Moderate to Severe Irritable Bowel Syndrome with Constipation
(IBS-C)," was authored by Taryn R. Joswick, Fasil Woldegeorgis and Ryuji
Ueno, all of Sucampo Pharmaceuticals, Inc.
About the Analysis
Data from two pivotal Phase 3, placebo-controlled, 12-week studies were
pooled and post-hoc analyses were conducted to evaluate improvements in
subsets of patients with moderate to very severe IBS-C. Patients with
documented IBS-C, as defined per Rome II criteria, were randomized in a
2:1 ratio to receive lubiprostone 8-mcg, or placebo, twice daily (BID),
for a 12-week treatment period in either of two pivotal, Phase 3,
A responder analysis of patients with mean weekly abdominal severity of
moderate or worse at baseline and less than 3 SBMs per week demonstrated
that a greater proportion of lubiprostone patients (N=199) reported ?30%
improvement form baseline in mean abdominal pain scores, ?1 SBM per week
improvement over baseline and ?3 SBMs per week compared to placebo
(N=119) for 6 of 12 weeks (24.1% vs. 9.2%, p=0.0031) and for 9 of 12
weeks (12.6% vs. 3.4%, p=0.0109). (Note that greater than or equal to 3
SBM's per week is generally considered to be within the normal range).
Lubiprostone was well tolerated throughout the study, with the most
common adverse events (greater than 4%) in these patients being nausea
(9.3% vs. 5.8%), headache (4.9% vs. 1.7%), and diarrhea (4.4% vs. 1.7%)
for lubiprostone vs. placebo, respectively. AMITIZA was well-tolerated
in this group of patients as well, with the most common adverse events
(greater than 4%) being nausea (9.8% vs. 5.7%), diarrhea (6.7% vs. 4.3%)
and upper respiratory infection (4.9% vs. 2.9%) for lubiprostone vs.
Patients reporting baseline abdominal pain of severe or very severe and
taking lubiprostone (n=183) reported statistically significant reduction
in abdominal pain overall on a weekly basis over 12 weeks of treatment
(p=0.0002) as compared to placebo (n=94), with 35.1% of patients
reporting a 30% or greater reduction in abdominal pain as compared to
baseline (p<0.0001 vs. placebo).
AMITIZA was approved for the treatment of IBS-C in women 18 yrs of age
and older by the Food and Drug Administration in 2008.
About AMITIZA for Chronic Idiopathic Constipation (CIC) and Irritable
Bowel Syndrome with Constipation (IBS-C)
AMITIZA is a chloride channel activator indicated for the treatment of
CIC (24 mcg twice daily) in adults and for IBS-C (8 mcg twice daily) in
women 18 years of age and older.
Important Safety Information
AMITIZA is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction. Patients with symptoms
suggestive of mechanical gastrointestinal obstruction should be
thoroughly evaluated by the treating healthcare provider to confirm the
absence of such an obstruction prior to initiating AMITIZA treatment.
The safety of AMITIZA in pregnancy has not been evaluated in humans.
AMITIZA should be used during pregnancy only if the benefit justifies
the potential risk to the fetus. Women who could become pregnant should
have a negative pregnancy test prior to beginning therapy with AMITIZA
and should be capable of complying with effective contraceptive measures.
Patients taking AMITIZA may experience nausea. If this occurs,
concomitant administration of food with AMITIZA may reduce symptoms of
nausea. Patients who experience severe nausea should inform their
AMITIZA should not be prescribed to patients that have severe diarrhea.
Patients should be aware of the possible occurrence of diarrhea during
treatment and inform their healthcare provider if the diarrhea becomes
Patients taking AMITIZA may experience dyspnea within an hour of first
dose. This symptom generally resolves within three hours, but may recur
with repeat dosing. Patients who experience dyspnea should inform their
healthcare provider. Some patients have discontinued therapy because of
In clinical trials of AMITIZA (24 mcg twice daily vs. placebo; N=1113
vs. N=316) in patients with Chronic Idiopathic Constipation (CIC), the
most common adverse reactions (incidence > 4%) were nausea (29% vs. 3%),
diarrhea (12% vs. <1%), headache (11% vs. 5%), abdominal pain (8% vs.
3%), abdominal distension (6% vs. 2%), and flatulence (6% vs. 2%).
In clinical trials of AMITIZA (8 mcg twice daily vs. placebo; N=1011 vs.
N=435) in patients with Irritable Bowel Syndrome with Constipation
(IBS-C), the most common adverse reactions (incidence > 4%) were nausea
(8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).
Reduce the dosage in CIC patients with moderate and severe hepatic
impairment. Reduce the dosage in IBS-C patients with severe hepatic
For further information please see complete Prescribing Information and
About Sucampo Pharmaceuticals
Sucampo Pharmaceuticals, Inc., an international pharmaceutical company
is focused on the discovery, development and commercialization of
proprietary drugs based on prostones. The therapeutic potential of
prostones, which occur naturally in the human body as a result of
enzymatic (15-PGDH) transformation of certain fatty acids, was first
identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals'
Chairman and Chief Executive Officer. Dr. Ueno founded Sucampo
Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding Chief
Executive Officer and currently Advisor, International Business
Development, and a member of the Board of Directors. For more
information, please visit www.sucampo.com.
Sucampo Forward-Looking Statements
This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management's current expectations and involve
risks and uncertainties, which may cause results to differ materially
from those set forth in the statements. The forward-looking statements
may include statements regarding product development, product potential,
future financial and operating results, and other statements that are
not historical facts. The following factors, among others, could cause
actual results to differ from those set forth in the forward-looking
statements: the impact of pharmaceutical industry regulation and health
care legislation; Sucampo's ability to accurately predict future market
conditions; dependence on the effectiveness of Sucampo's patents and
other protections for innovative products; the risk of new and changing
regulation and health policies in the US and internationally and the
exposure to litigation and/or regulatory actions.
No forward-looking statement can be guaranteed and actual results may
differ materially from those projected. Sucampo undertakes no obligation
to publicly update any forward-looking statement, whether as a result of
new information, future events, or otherwise. Forward-looking statements
in this presentation should be evaluated together with the many
uncertainties that affect Sucampo's business, particularly those
mentioned in the risk factors and cautionary statements in Sucampo's
Form 10-K for the year ended Dec. 31, 2011, which the Company
incorporates by reference.
Sucampo Pharmaceuticals, Inc.
Kate de Santis, 1-240-223-3834