Sucampo Announces Presentation of Results on Lubiprostone in Pediatric
Functional Constipation at NASPGHAN 2013
BETHESDA, Md., Oct. 10, 2013 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc.
(Nasdaq:SCMP) ("Sucampo") today announced the presentation of results from a
Phase 3, open-label safety and efficacy study of lubiprostone in patients with
pediatric functional constipation. These results demonstrate that lubiprostone
increased spontaneous bowel movement (SBM) frequency and was well-tolerated in
subgroups of children and adolescents with functional constipation. These
results will be presented at the North American Society for Pediatric
Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting in
Chicago, Illinois on October 11, 2013.
Lubiprostone is the world's first chloride channel activator that increases
intestinal fluid secretion, softens stools and increases intraluminal fluid
volume to initiate colonic transit and improve bowel function independent of
motility, thereby alleviating symptoms associated with chronic constipation.
The completed open-label, multicenter study evaluated both safety and efficacy
in a total of 124 children and adolescents (ranging from 3 years through 17
years of age) with functional constipation who were dosed with lubiprostone 12
mcg once daily (QD), 12 mcg twice daily (BID), or 24 mcg BID.
"Pediatric functional constipation accounts for 3-5% of pediatric outpatient
visits^1 and there is a definite need for new treatment options," said Paul
Hyman, MD, lead author, Professor of Pediatrics at Louisiana State University
and Chief, Gastroenterology at Children's Hospital. "The positive response
reported by children and adolescents in this study shows that lubiprostone may
represent a promising option for treating the broad range of patients who
suffer from pediatric constipation."
In the fourth quarter of this year, Sucampo plans to initiate a series of
global, multicenter Phase 3 studies to evaluate the efficacy, safety, and
pharmacokinetics of lubiprostone in patients aged ≥ 6 months through 17 years
of age with pediatric functional constipation. This program will consist of
two randomized, placebo-controlled, double-blinded studies and two long-term
safety extension studies.
The following poster will be presented by Dr. Hyman during the Poster Session
at NASPGHAN on Friday, October 11, 2013, between 12:15PM to 2:15PM CT:
*Efficacy of Lubiprostone for Treating Functional Constipation in Children
and Adolescents in an Open-Label Multicenter Study (Paul Hyman, MD, Taryn
Joswick, BS, PMP, Ryuji Ueno, MD, PhD, PhD) Poster 287
Additional information about NASPGHAN's Annual Meeting can be found at
About Pediatric Functional Constipation
Pediatric functional constipation has similar characteristics to that of
constipation in adults in that symptoms include infrequent bowel movements
(BMs), hard stools, and painful passage of stools.Children may also
experience fecal retention due to withholding.^2,3 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.Pediatric functional constipation occurs in all age
groups, from newborns to young adults, and its severity may vary from mild and
short-lived to severe and chronic with fecal impaction. It is responsible for
3–5% of pediatric outpatient visits and 25% of pediatric gastroenterology
consultations.^1, 2, 3
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) 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
*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 a global biopharmaceutical company focused on
innovative research, discovery, development and commercialization of
proprietary drugs based on prostones. The therapeutic potential of prostones
was first discovered by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo's Chairman,
Chief Executive Officer, Chief Scientific Officer, and co-founder. Prostones,
naturally occurring fatty acid metabolites that have emerged as promising
compounds with unique physiological activities, can be targeted for the
treatment of unmet or underserved medical needs. For more information, please
The Sucampo logo and the tagline, The Science of Innovation, are registered
trademarks of Sucampo AG.AMITIZA is a registered trademark of Sucampo AG.
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.
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1. Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A,
Walker LS. Childhood functional gastrointestinal disorders:
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2. Baker SS, Liptak GS, Colletti RB, Croffie JM, Di Lorenzo C, Ector W,
Nurko S. Constipation in infants and children: evaluation and treatment. A
medical position statement of the North American Society for Pediatric
Gastroenterology and Nutrition. J Pediatr Gastroenterol Nutr 1999
3. Biggs WS, Dery WH. Evaluation and treatment of constipation in infants
and children. Am Fam Physician 2006 Feb;73(3):469–77.
CONTACT: Silvia Taylor
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