Clinical Data Show That Lubiprostone is Efficacious and Well Tolerated in
Children and Adolescents With Functional Constipation
Results Published in Journal of Pediatric Gastroenterology & Nutrition
BETHESDA, Md., Oct. 8, 2013 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc.
(Nasdaq:SCMP) ("Sucampo"), today announced clinical data showing that
lubiprostone is efficacious and well tolerated in children and adolescents
with functional constipation. The results were published in the Journal of
Pediatric Gastroenterology & Nutrition.
The primary endpoint for the open-label, multicenter, safety and efficacy
study was spontaneous bowel movement (SBM) frequency during week 1 versus
baseline. The mean SBM frequency significantly increased from 1.5 SBMs/week at
baseline to 3.1 SBMs/week at week 1. In addition, lubiprostone was associated
with statistically significant improvements in SBM frequency from baseline for
up to three additional weeks.
The study enrolled 127 patients between the ages of 3 and 17 at 22 U.S.
general pediatric and pediatric gastroenterology centers who weighed at least
12 kg or more, and who reported having fewer than 3 SBMs per week on average.
Patients received four weeks of lubiprostone at doses (12 mcg once daily [QD],
12 mcg twice daily [BID], or 24 mcg [BID]) based on age and weight. Of the 127
patients, 124 were treated and analyzed (12 mcg QD, n = 27; 12 mcg BID,
n = 65; 24 mcg BID, n = 32), and 109 completed the study. The mean age of
treated patients was 10.2 years, and 52% were male.
Common adverse events (AEs) included nausea (18.5%), vomiting (12.1%),
diarrhea (8.1%), abdominal pain (7.3%), and headache (5.6%). Two patients
experienced serious AEs (unrelated abdominal pain; unrelated sickle cell
"Pediatric functional constipation is a common disorder, however there are
currently no available prescription treatment options in this patient
population," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive
Officer, and Chief Scientific Officer of Sucampo. "The results of this study
support lubiprostone' s potential to become the first prescription treatment
option available for children suffering from constipation. Sucampo plans to
initiate a late-stage clinical development program, which will consist of two
Phase 3, 12-week, placebo-controlled studies, to evaluate lubiprostone for the
treatment of pediatric functional constipation later this year."
More information about the study can be found on ClinicalTrials.gov:
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 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 also a registered trademark of 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
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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CONTACT: Silvia Taylor
Senior Vice President, IR, PR, and Corporate Communications
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