Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Takeda
Pharmaceuticals U.S.A., Inc. (TPUSA) announced today that the United
States (U.S.) Food and Drug Administration (FDA) has approved Sucampo's
supplemental new drug application (sNDA) for AMITIZA®
(lubiprostone) (24 mcg twice daily) as the first and only oral
medication for the treatment of opioid-induced constipation (OIC) in
adult patients with chronic, non-cancer pain. The effectiveness of
AMITIZA in the treatment of opioid-induced constipation in patients
taking diphenylheptane opioids (e.g., methadone) has not been
This is the third indication for AMITIZA, which is also approved in the
U.S. for the treatment of chronic idiopathic constipation (CIC) in
adults (24 mcg twice daily) and irritable bowel syndrome with
constipation (IBS-C) in adult women (8 mcg twice daily). There are more
than 200 million prescriptions for opioid use in the U.S. annually, and
a substantial number of these prescriptions are for non-cancer chronic
pain.Scientific literature indicates that approximately
40-80% of patients taking opioids chronically for non-cancer pain report
"This approval from the FDA, which received priority review status,
provides the first and only oral treatment option for opioid-induced
constipation in adult patients with chronic, non-cancer pain. As a
locally acting ClC-2 channel activator, AMITIZA enhances chloride
secretion together with intestinal fluid, which is important in its role
in treating OIC," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief
Scientific Officer, and Chief Executive Officer, Sucampo. "With this
third indication for AMITIZA, we are pleased to be able to provide
physicians an important new option to help treat the unmet needs of
Opioid-based medicines are widely used in the management of chronic
pain, with OIC being a common adverse effect of chronic opioid use. Some
patients may discontinue opioid therapy and thereby endure pain rather
than suffer from the constipation the opioids cause.
"We are pleased with the FDA approval of this new indication for
AMITIZA," said Charlie Baum, Vice President, U.S. Medical Affairs,
Takeda. "It is critical that we continue to identify and respond to the
needs of physicians and their patients with OIC."
AMITIZA is a specific activator of ClC-2 chloride channels in the
intestinal epithelium. AMITIZA, via activation of apical ClC-2 channels
in the intestinal epithelium, bypasses the antisecretory action of
This approval is based on results from Phase 3, well-controlled studies
of 12 weeks' duration in patients taking opioids (among them morphine,
oxycodone, and fentanyl) chronically for non-cancer pain, as well as a
long-term, open-label safety study, which provides additional support
for use in this population. Two of the Phase 3 studies met their overall
efficacy endpoint, while a third Phase 3 study did not.
About Opioid Induced Constipation (OIC)
OIC is a common adverse effect of chronic opioid use. Binding of opioids
to peripheral opioid receptors in the gastrointestinal tract results in
absorption of electrolytes, such as chloride, and subsequent reduction
in small intestinal fluid. In addition, activation of enteric opioid
receptors results in abnormal GI motility. Together, these processes
result in OIC, which is characterized by infrequent and incomplete
evacuation of stool, hard stool consistency, and straining associated
with bowel movements.
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 (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
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
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 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
For further information, please visit www.sucampo.com/products
for complete Prescribing Information.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a global pharmaceutical 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 visit www.sucampo.com.
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.
Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research &
Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda
Global Research & Development Center, 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 treatments
and seek to bring innovative products to patients through a pipeline
that includes compounds in development for metabolic and cardiovascular
disease, gastroenterology, neurology and other conditions. To learn more
about these Takeda companies, visit www.takeda.us.
Takeda Forward-Looking Statement
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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
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"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 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.
Sucampo Pharmaceuticals, Inc.
Silvia Taylor, 1-240-223-3718
Pharmaceuticals U.S.A., Inc.
Jessica Tuquero, 1-224-554-2021