Sucampo and Takeda Initiate Pivotal Trial of Lubiprostone Liquid Formulation
in Adults With Chronic Idiopathic Constipation
BETHESDA, Md. and DEERFIELD, Ill., Oct. 23, 2013 (GLOBE NEWSWIRE) -- Sucampo
Pharmaceuticals, Inc. (Nasdaq:SCMP) ("Sucampo") and its development and
commercialization partner Takeda Pharmaceuticals U.S.A., Inc. (Takeda) today
announced that Sucampo Pharma Americas, LLC (SPA) initiated a pivotal clinical
trial of a liquid form of lubiprostone 24 mcg BID in adult subjects with
chronic idiopathic constipation (CIC).
U.S.A., Inc. logo
Lubiprostone is the world's first chloride channel activator that increases
intestinal fluid secretion, softens stools and increases motility in the
intestine. This facilitates the passage of stool and alleviates symptoms
associated with CIC.
"We are very pleased to announce the initiation of this trial of a new
lubiprostone formulation, as many physicians are interested in additional
dosing options for their patients," said Ryuji Ueno, M.D., Ph.D., Ph.D.,
Chairman, Chief Executive Officer, and Chief Scientific Officer of Sucampo.
"While lubiprostone has been approved and is available in the United States,
Japan, the United Kingdom and Switzerland, there is still an unmet need in
patients who suffer from CIC but will not take lubiprostone in its current
capsule form. If approved, alternative dosing options for this CIC patient
population, as well as those suffering from OIC, can play an important role in
making lubiprostone treatment available to a wider range of patients who may
This pivotal trial is a randomized, placebo-controlled, double-blinded,
multi-center study of the pharmacodynamics, pharmacokinetics, and tolerability
of a liquid form of lubiprostone in adult subjects ≥18 years of age with a
confirmed diagnosis of chronic constipation. The trial is expected to enroll
152 patients with CIC at approximately 11 sites in the United States.
Sucampo plans to file an NDA upon review of the results of the trial, which is
anticipated to end in 2014.Sucampo also plans to study the liquid formulation
of lubiprostone in children as part of its upcoming global, multicenter Phase
3 program to study lubiprostone in pediatric functional constipation.
Lubiprostone is available under the brand name AMITIZA® in the U.S.AMITIZA
capsules are indicated for the treatment of chronic idiopathic constipation
(CIC) in adults and opioid induced constipation (OIC) in adults with chronic,
non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC
taking diphenylheptane opioids (e.g., methadone) has not been established.
AMITIZA is also indicated for irritable bowel syndrome with constipation
(IBS-C) in women > 18 years old (8 mcg twice daily).
Important Safety Information
*AMITIZA (lubiprostone) 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 (HCP) to confirm the absence
of such an obstruction prior to initiating AMITIZA treatment.
*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 HCP.
*AMITIZA should not be prescribed to patients that have severe diarrhea.
Patients should be aware of the possible occurrence of diarrhea during
treatment. Patients should be instructed to discontinue AMITIZA and inform
their HCP if severe diarrhea occurs.
*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
HCP. Some patients have discontinued therapy because of dyspnea.
*In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs
N=316, respectively) in patients with 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 (24 mcg twice daily vs. placebo; N=860 vs.
N=632, respectively) in patients with OIC, the most common adverse
reactions (incidence > 4%) were nausea (11% vs 5%) and diarrhea (8% vs
*In clinical trials of AMITIZA (8 mcg twice daily vs. placebo; N=1011 vs.
N=435, respectively) in patients with IBS-C the most common adverse
reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%),
and abdominal pain (5% vs 5%).
*Concomitant use of diphenylheptane opioids (e.g., methadone) may interfere
with the efficacy of AMITIZA.
*The safety of AMITIZA in pregnancy has not been evaluated in humans. Based
on animal data, AMITIZA may cause fetal harm. AMITIZA should be used
during pregnancy only if the potential benefit justifies the potential
risk to the fetus. Caution should be exercised when AMITIZA is
administered to a nursing woman. Advise nursing women to monitor infants
*Reduce the dosage in CIC and OIC patients with moderate and severe hepatic
impairment. Reduce the dosage in IBS-C patients with severe hepatic
For further information, please visit www.sucampo.com/productsfor complete
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is focused on the discovery, development and
commercialization of drugs based on ion channel activators knows as prostones.
Discovered by the company's scientific founder, prostones are naturally
occurring fatty acid metabolites with unique physiological activities. Sucampo
has two marketed products – AMITIZA^® and RESCULA^® – and a pipeline of
prostone-based product candidates in clinical development. A global company,
Sucampo is headquartered in Bethesda, Maryland, and has operations in the
United Kingdom, Switzerland and Japan. For more information, please visit
The Sucampo logo and the tagline, The Science of Innovation, are registered
trademarks of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG.
Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo
Sucampo Forward-Looking Statement
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
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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
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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
U.S. 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 most recent Form 8-K and 10-K, which
Sucampo incorporates by reference.
Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development
Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda
Global Research & Development Center, Inc. are subsidiaries of Takeda
Pharmaceutical Company Limited, the largest pharmaceutical company in Japan.
The respective companies currently market oral diabetes, insomnia,
rheumatology, gastroenterology, and cardiovascular treatments and seek to
bring innovative products to patients through a pipeline that includes
compounds in development for metabolic and cardiovascular disease,
gastroenterology, neurology and other conditions. To learn more about these
Takeda companies, visit www.takeda.us.
Takeda Forward-Looking Statement
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believed to be reasonable, though they are inherently uncertain and difficult
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Forward-looking statements involve risks and uncertainties that could cause
actual results or experience to differ materially from that expressed or
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uncertainties include, but are not limited to, (1) the economic circumstances
surrounding Takeda's business, including general economic conditions in Japan,
the United States and worldwide; (2) competitive pressures and developments;
(3) applicable laws and regulations; (4) the success or failure of product
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thereof; (6) changes in exchange rates; (7) claims or concerns regarding the
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and (8) integration activities with acquired companies.
The forward-looking statements contained in this press release speak only as
of the date of this press release, and Takeda undertakes no obligation to
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updates or corrections.
CONTACT: Silvia Taylor
Senior Vice President, IR, PR, and Corporate Communications
Takeda Pharmaceuticals U.S.A., Inc.
Sandy Rodriguez, 1-224-554-5693
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