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FDA Accepts Sucampo's sNDA for Lubiprostone (8 mcg) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C)
BETHESDA, Maryland, September 18 /PRNewswire/ --
- Lower Strength of Approved Constipation Drug Offers Potential Treatment
Option to Americans Suffering from IBS-C
Sucampo Pharmaceuticals, Inc., (Nasdaq: SCMP) today 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%).
BETHESDA, Maryland, September 18 /PRNewswire/ --
For full prescribing information, visit www.amitiza.com.
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 www.sucampo.com.
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.
Contact:
Scott Solomon
Vice President
Sharon Merrill Associates, Inc.
Tel: +1-617-542-5300
Web site: http://www.sucampo.com
http://www.amitiza.com






