Sucampo Announces Clinical Data on Lubiprostone to be Presented at Digestive Disease Week
May 15 2015 - 4:02PM
Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global
biopharmaceutical company, today announced that clinical data for
lubiprostone will be presented at Digestive Disease Week ("DDW")
2015 in Washington, D.C. Information regarding the presentations
can be found below.
The following poster will be presented at DDW on Saturday, May
16th from 12:00 – 2:00 PM at the Walter E. Washington Convention
Center:
Durability and Predictability of
Response to Lubiprostone in Patients With Opioid- Induced
Constipation (Egilius L. Spierings, MD, PhD; Taryn R.
Losch-Beridon; Martin Wang, MS; Peter Lichtlen, MD, PhD, BBA;
Shadreck M. Mareya, PhD – Poster #Sa1394)
The following poster will be presented at DDW on Monday, May
18th from 12:00 – 2:00 PM at the Walter E. Washington Convention
Center:
Effects of Baseline Abdominal Pain on
Response to Lubiprostone in Patients With Constipation-Predominant
Irritable Bowel Syndrome (Lin Chang, MD; William D. Chey, MD;
Douglas A. Drossman, MD, FACP, AGAF, MACG; Taryn R. Losch-Beridon;
Martin Wang, MS; Peter Lichtlen, MD, PhD, BBA; Shadreck M. Mareya,
PhD – Poster #Mo1262)
About lubiprostone (AMITIZA®)
AMITIZA (lubiprostone) is a chloride channel activator that acts
locally in the small intestine. By increasing intestinal fluid
secretion, lubiprostone increases motility in the intestine,
thereby facilitating the passage of stool and alleviating symptoms
associated with chronic idiopathic constipation. Lubiprostone, via
activation of apical CIC-2 channels in intestinal epithelial cells,
bypasses the antisecretory action of opiates that results from
suppression of secretomotor neuron excitability. Activation of
CIC-2 by lubiprostone has also been shown to stimulate recovery of
mucosal barrier function and reduce intestinal permeability via the
restoration of tight junction protein complexes in ex vivo studies
of ischemic porcine intestine.
AMITIZA (24 mcg twice daily) is indicated in the U.S. for the
treatment of adults with CIC and OIC with chronic, non-cancer pain.
AMITIZA (8 mcg twice daily) is also approved in the U.S. for IBS-C
in women 18 years of age and older. In Japan, AMITIZA (24 mcg twice
daily) is indicated for the treatment of chronic constipation
(excluding constipation caused by organic diseases). In the U.K.,
AMITIZA (24 mcg twice daily) is indicated for the treatment of CIC
and associated symptoms in adults, when response to diet and other
non-pharmacological measures (e.g. educational measures, physical
activity) are inappropriate. In Switzerland, AMITIZA (24 mcg twice
daily) is indicated for the treatment of CIC in adults and for the
treatment of OIC and associated signs and symptoms such as stool
consistency, straining, constipation severity, abdominal
discomfort, and abdominal bloating in adults with chronic,
non-cancer pain. The efficacy of AMITIZA for the treatment of OIC
in patients taking opioids of the diphenylheptane class, such as
methadone, has not been established.
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 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 see the Full Prescribing Information here. For further
information on AMITIZA, please visit
http://www.sucampo.com/products.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., is a global biopharmaceutical
company that is built on the ongoing pursuit of scientific
innovation to improve the lives of patients. Sucampo has a marketed
product – AMITIZA – and a pipeline including lifecycle management
and clinical development programs. Sucampo is headquartered in
Bethesda, Maryland, and has operations in Japan, Switzerland and
the U.K. 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.
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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; the ability of Sucampo to continue to
develop the market for AMITIZA; the ability of Sucampo to develop,
commercialize or license existing pipeline products or compounds or
license or acquire non-prostone products or drug candidates;
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; the
effects of competitive products on Sucampo's products; 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
10-K as filed with the Securities and Exchange Commission on March
9, 2015 as well as its filings with the Securities and Exchange
Commission on Forms 8-K and 10-Q since the filing of the Form 10-K,
all of which Sucampo incorporates by reference.
CONTACT: Silvia Taylor
Senior Vice President,
Investor Relations and Corporate Communications
240-223-3718
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