Sucampo to Present Results From Four Phase 3 Studies of AMITIZA(R)
(lubiprostone) for Opioid-Induced Constipation at PAINWeek 2013
BETHESDA, Md., Sept. 4, 2013 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc.
(Nasdaq:SCMP) ("Sucampo") will be presenting data from four separate phase 3
studies evaluating the overall efficacy of AMITIZA (lubiprostone) as a
treatment for adults with chronic, non-cancer pain suffering from
opioid-induced constipation (OIC). One of the presentations will also include
results of AMITIZA's long-term safety and another will highlight novel data
indicating that the treatment does not interfere with the analgesic effect of
opioids in adult patients. Sucampo will present these data during PAINWeek
2013 in Las Vegas on Thursday, September 5, at 6:15 p.m. PDT.
"Oral lubiprostone has been demonstrated to significantly improve OIC
symptoms, and continues to be well tolerated by patients," said Sucampo's
Chairman, Chief Executive Officer, and Chief Scientific Officer Ryuji Ueno,
M.D., Ph.D., Ph.D. "We are pleased to present these data that build on the
body of clinical evidence and real-world experience that support AMITIZA as a
treatment for OIC."
AMITIZA 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 constipation. Based on the data to be presented,
AMITIZA does not interfere with the analgesic effect of opioids in adult
The following posters will be presented during the Poster Session at PAINWeek
2013 on Thursday, September 5, between 6:15 p.m. – 7:30 p.m. PDT at Level 2,
*A phase 3, randomized, double-blind, placebo-controlled clinical trial of
lubiprostone for the treatment of opioid-induced constipation in patients
with chronic, non-cancer pain
*Byron Cryer, MD, Seymour Katz, MD, Taryn R. Joswick, BS, PMP, Gayle R.
Dolecek, PD, MPH, Ryuji Ueno, MD, PhD, PhD, Poster 44
*Lubiprostone for Treatment of Opioid-Induced Constipation Does Not
Interfere With Opioid Analgesic Effects in Patients With Non-Cancer Pain
*Egilius L. H. Spierings, MD, PhD, Taryn Joswick, BS, PMP, Shadreck
Mareya, PhD, Yijun Sun, PhD, Ryuji Ueno, MD, PhD, PhD, Poster 60
*Lubiprostone significantly improves constipation induced by non-methadone
opioids in patients with chronic, non-cancer pain: results from a phase 3,
randomized, double-blind, placebo-controlled clinical trial
*M. Mazen Jamal, MD, MPH, Shadreck M. Mareya, PhD, Taryn R. Joswick, BS,
PMP, Ryuji Ueno, MD, PhD, PhD, Poster 61
*Long-term safety and efficacy of lubiprostone in opioid-induced
constipation in patients with chronic, non-cancer pain: results from a
phase 3, open-label clinical trial
*Spierings, Egilius L., Joswick, Taryn, Lindner, Elizabeth, Woldegeorgis,
Fasil, Ueno, Ryuji, Poster 43
Additional information about the PAINWeek 2013 conference can be found at
AMITIZA (lubiprostone) 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/products for 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
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
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