Sucampo
Pharmaceuticals, Inc., (Nasdaq: SCMP) announced that the supplemental
New Drug Application (sNDA) for lubiprostone (8 mcg, oral gel capsules,
twice daily) for the treatment of irritable bowel syndrome with
constipation (IBS-C) has been accepted for review by the U.S. Food and Drug
Administration (FDA). Sucampo Pharmaceuticals currently anticipates a
decision from the FDA in the second quarter of 2008.
Lubiprostone, a chloride channel activator with a novel mechanism of
action, was developed by Sucampo Pharmaceuticals. The 24-mcg formulation of
the drug (AMITIZA(R)) is approved for the treatment of Chronic Idiopathic
Constipation in adults and is marketed for this indication in the United
States by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America,
Inc.
"The FDA's decision to accept our sNDA submission for review is an
important step in filling an unmet medical need for patients with the
debilitating disease of IBS-C," said Ryuji Ueno, M.D., Ph.D., Ph.D.,
founder, chairman and chief executive officer of Sucampo Pharmaceuticals.
"IBS-C has a significant impact on millions of Americans and, if approved,
lubiprostone may offer a valuable new treatment option for people living
with this condition."
Approximately 58 million Americans have irritable bowel syndrome (IBS),
with IBS-C accounting for approximately one-third of these cases. IBS-C
symptoms include abdominal pain and discomfort associated with defecation
or a change in bowel habits with features of disordered defecation.
About lubiprostone (8 mcg) and its supplemental New Drug Application
The sNDA, filed with the FDA on June 29, 2007, was based on a clinical
study program that included two Phase 3, multi-center, double-blinded,
randomized, placebo-controlled trials involving 1,171 adults, followed by
one long-term, open-label safety and efficacy extension trial involving 522
adults diagnosed with IBS-C. In the two Phase 3 trials, patients received
lubiprostone 8 mcg twice daily or placebo twice daily over a 12-week
period. Patients receiving lubiprostone were nearly twice as likely to
achieve overall relief that was statistically significant compared to those
receiving placebo (17.9% vs. 10.1%; P=0.001). Individually, each study
showed lubiprostone's efficacy over placebo for overall relief (P=0.009 and
P=0.031). In the combined studies, secondary endpoints included abdominal
discomfort/pain, stool consistency, straining, constipation severity and
quality of life; these endpoints showed statistically significant
improvement in patients receiving lubiprostone vs. placebo. The long-term
extension trial demonstrated that the efficacy of lubiprostone continued
through the open-label period, with increasing overall improvement to the
end of the 52-week program.
In the two Phase 3 pivotal trials, lubiprostone and placebo groups
showed a similar incidence of serious adverse events (1% in both the
lubiprostone and placebo groups) and related adverse events (22% in
lubiprostone vs. 21% in the placebo group). The most common
treatment-related adverse events (>5% of patients) were nausea (8% vs. 4%,
respectively), diarrhea (6% vs. 4%, respectively) and abdominal pain (4%
vs. 5%, respectively).
About Irritable Bowel Syndrome with Constipation (IBS-C)
IBS is a chronic functional bowel disorder in which abdominal
discomfort or pain is associated with defecation or a change in bowel habit
and with features of disordered defecation. IBS is further sub-classified
into IBS with constipation, IBS with diarrhea and mixed IBS, depending upon
stool consistency. Patients with IBS-C have hard or lumpy stools, but
unlike patients with chronic constipation the frequency of bowel movements
is not part of the diagnostic criteria.
It is the temporal relationship of pain, bowel habit and stool
characteristics that is the most prominent feature of IBS-C. The
hypersensitivity of the gastrointestinal system of individuals with IBS-C
makes them more prone to experience the effects of even mild symptoms
associated with defecation or a change in bowel habit. In contrast to
chronic constipation, the treatment of IBS-C is directed toward the
improvement of the dominant symptoms (abdominal discomfort/pain and stool
consistency) rather than increasing the frequency of bowel movements.
About AMITIZA(R) (lubiprostone 24 mcg) Twice Daily for Chronic
Idiopathic Constipation
AMITIZA (24 mcg, oral gel capsules, twice daily) is indicated for the
treatment of Chronic Idiopathic Constipation in adults. AMITIZA should not
be used in patients with a known gastrointestinal obstruction. Patients
with symptoms suggestive of mechanical gastrointestinal obstruction should
be evaluated 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. In
guinea pigs, lubiprostone has been shown to have the potential to cause
fetal loss. 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.
AMITIZA should not be administered to patients that have severe
diarrhea. Patients should be aware of the possible occurrence of diarrhea
during treatment. If the diarrhea or nausea becomes severe, patients should
consult their health professional.
In clinical trials for Chronic Idiopathic Constipation (24 mcg, oral
gel capsules, twice daily), the most common adverse reaction was nausea
(29%). Other adverse reactions (greater than or equal to 4% of patients)
included diarrhea (12%), headache (11%), abdominal pain (8%), abdominal
distension (6%) and flatulence (6%).
AMITIZA(R) is a registered trademark of Sucampo Pharmaceuticals, Inc.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., an emerging pharmaceutical company based
in Bethesda, Md., focuses on the development and commercialization of drugs
based on prostones, a class of compounds derived from functional fatty
acids that occur naturally in the human body. The therapeutic potential of
prostones 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 advisor, international business development. Sucampo
Pharmaceuticals' first product, AMITIZA(R), received marketing approval
from the U.S. Food and Drug Administration in January 2006 for the
treatment of Chronic Idiopathic Constipation in adults. AMITIZA is
co-promoted in the United States through an alliance between Sucampo
Pharmaceuticals and Takeda Pharmaceutical Company Limited (Osaka, Japan).
To learn more about Sucampo Pharmaceuticals and its products, visit
sucampo.
Forward-Looking Statements
Any statements in this press release about future expectations, plans
and prospects for Sucampo Pharmaceuticals are forward-looking statements
made under the provisions of The Private Securities Litigation Reform Act
of 1995. Forward-looking statements may be identified by the words
"project," "believe," "anticipate," "plan," "expect," "estimate," "intend,"
"should," "would," "could," "will," "may" or other similar expressions.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important factors,
including risks relating to: the results of clinical trials with respect to
Sucampo Pharmaceuticals' products under development; the timing and success
of submission, acceptance, review and approval of regulatory filings;
Sucampo Pharmaceuticals' dependence on the commercial success of AMITIZA;
Sucampo Pharmaceuticals' ability to obtain additional funding required to
conduct its discovery, development and commercialization programs; Sucampo
Pharmaceuticals' dependence on its co- marketing alliance with Takeda
Pharmaceutical Company Limited; and Sucampo Pharmaceuticals' ability to
obtain, maintain and enforce patent and other intellectual property
protection for its discoveries. These and other risks are described in
greater detail in the "Risk Factors" section of the Sucampo
Pharmaceuticals' quarterly report on Form 10-Q filed with the Securities
and Exchange Commission on August 22, 2007. Any forward-looking statements
in this press release represent Sucampo Pharmaceuticals' views only as of
the date of this release and should not be relied upon as representing its
views as of any subsequent date. Sucampo Pharmaceuticals anticipates that
subsequent events and developments will cause its views to change. However,
while Sucampo Pharmaceuticals may elect to update these forward-looking
statements publicly at some point in the future, it specifically disclaims
any obligation to do so, whether as a result of new information, future
events or otherwise.
Sucampo Pharmaceuticals, Inc.
sucampo
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