Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) ("Sucampo") and its
development and commercialization partner Takeda Pharmaceuticals
("Takeda") today announced the initiation of a global pivotal Phase
3 clinical program of lubiprostone in pediatric functional
constipation. Functional constipation is a very common
gastrointestinal complaint in children and is on the rise. An
analysis of longitudinal data in the United States showed a nearly
4-fold increase in rates of constipation over the last decade.1
Lubiprostone is the world's first chloride channel activator
that increases intestinal fluid secretion, softens stools and
increases motility in the intestine, thereby facilitating the
passage of stool and alleviating symptoms associated with chronic
idiopathic constipation. This Phase 3 program was preceded by an
open-label trial in 124 patients aged 3 to 17 years, which
suggested that lubiprostone warrants further investigation as a
potential treatment for children and adolescents with functional
constipation.
Estimates of the prevalence rate of functional constipation in
the pediatric population worldwide have varied from 4 to 37%.2 Only
50 to 70% of children with functional constipation demonstrate
long-term improvement with the current treatments.3
"I am very pleased to be participating in this pivotal program
which will study lubiprostone for pediatric functional
constipation," said Paul Hyman, MD, Investigator and Professor of
Pediatrics, Division Head, Gastroenterology, Children's Hospital at
New Orleans, Louisiana State University Health Science Center.
"There is an unmet need for alternatives to traditional laxative
therapy in the pediatric population, and there are currently no
prescription products indicated for long-term use in this
population. We look forward to conducting this study to determine
whether lubiprostone may be a valuable treatment alternative for
these pediatric patients."
This Phase 3 program consists of two well-controlled pivotal
studies with similar design – one testing lubiprostone capsules in
patients 6 to 17 years of age and another testing lubiprostone
liquid formulation in patients aged 6 months to under 6 years.
Sucampo also plans to evaluate the long-term safety of lubiprostone
in these populations through two open-label extension studies.
The first Phase 3 trial in the program, which has just been
initiated, is a randomized, placebo-controlled, double-blind study
of the efficacy, safety and pharmacokinetics of lubiprostone in
pediatric subjects between the ages of 6 to 17. The trial is
expected to enroll more than 500 patients with pediatric functional
constipation at up to 100 sites across the United States, Canada,
and Europe. Subjects will be treated for 12 weeks with weight-based
dosages of 12 mcg or 24 mcg twice daily (BID). The primary endpoint
for this trial is overall spontaneous bowel movement (SBM)
response. An SBM is a bowel movement that occurs without the use of
another constipation treatment such as a laxative, enema, or
suppository, during the 24 hours prior to occurrence.
Sucampo plans to file a supplemental new drug application with
the U.S. Food and Drug Administration following program completion,
which is anticipated by early 2016.
About Pediatric Functional Constipation
The symptoms of pediatric functional constipation include
infrequent bowel movements (BMs), hard stools, large diameter
stools and painful passage of stools. Rome III diagnostic criteria
for childhood functional constipation dictate that such symptoms
occur at least once per week for at least 2 months prior to
diagnosis. Children may also experience fecal retention due to
withholding.1 There is a tendency to avoid defecation and withhold
BMs as a result of pain experienced from the passage of large
stools. This withholding of BMs can result in episodes of fecal
incontinence. Ninety percent of pediatric constipation is
functional constipation and it occurs in all age groups.4
About lubiprostone
Amitiza® (lubiprostone) 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 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 2%).
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 for diarrhea.
Reduce the dosage in CIC and OIC patients with moderate and
severe hepatic impairment. Reduce the dosage in IBS-C patients with
severe hepatic impairment.
Please visit www.sucampo.com/products for complete
Prescribing Information and for further information.
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 www.sucampo.com.
The Sucampo logo and the tagline, The Science of Innovation, are
registered trademarks of Sucampo AG. AMITIZA is a registered
trademark of Sucampo AG. RESCULA is a registered trademark of
R-Tech Ueno, Ltd, and has been licensed to Sucampo AG.
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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 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
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.
About Takeda Pharmaceuticals U.S.A., Inc. and Takeda
Development Center Americas, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc.
and Takeda Development Center Americas, 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 disease treatments and seek to bring innovative
products to people through a pipeline that includes compounds in
development for diabetes, gastroenterology, neurology and other
conditions. To learn more about these Takeda companies, visit
www.takeda.us.
Takeda Forward-Looking Statement
This press release contains forward-looking statements.
Forward-looking statements include statements regarding Takeda's
plans, outlook, strategies, results for the future, and other
statements that are not descriptions of historical facts.
Forward-looking statements may be identified by the use of
forward-looking words such as "may," "believe," "will," "expect,"
"project," "estimate," "should," "anticipate," "plan," "assume,"
"continue," "seek," "pro forma," "potential," "target," "forecast,"
"guidance," "outlook" or "intend" or other similar words or
expressions of the negative thereof. Forward-looking statements are
based on estimates and assumptions made by management that are
believed to be reasonable, though they are inherently uncertain and
difficult to predict. Investors are cautioned not to unduly rely on
such forward-looking statements.
Forward-looking statements involve risks and uncertainties that
could cause actual results or experience to differ materially from
that expressed or implied by the forward-looking statements. Some
of these risks and 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 development programs; (5) actions of regulatory authorities
and the timing thereof; (6) changes in exchange rates; (7) claims
or concerns regarding the safety or efficacy of marketed products
or product candidates in development; 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 revise or update any forward-looking
statements to reflect new information, future events or
circumstances after the date of the forward-looking statement. If
Takeda does update or correct one or more of these statements,
investors and others should not conclude that Takeda will make
additional updates or corrections.
Sources:
1. Rajindrajith S. et al Constipation in Children: Novel Insight
Into Epidemiology, Pathophysiology and Management. J
Neurogastroenterol Motil 2011 January;17(1):35–47.
2. Loening-Baucke V. Prevalence rates for constipation and
faecal and urinary incontinence. Arch Dis Child 2007
Jun;92(6):486-9.
3. Biggs WS. et al Evaluation and treatment of constipation in
infants and children. Am Fam Physician 2006 Feb;73(3):469–77.
4. Mugie S. et al Constipation in childhood. Nature Reviews
Gastroenterology and Hepatology 2011 Sept;8:502-511
CONTACT: Silvia Taylor
Senior Vice President, IR, PR, and
Corporate Communications
1-240-223-3718
staylor@sucampo.com
Roseanne Durril
Takeda Pharmaceuticals U.S.A., Inc.
1-224-554-1474
roseanne.durril@takeda.com
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