Sucampo Announces Approval of a Supplemental Application for Updates to
AMITIZA (lubiprostone) Pregnancy Labeling
Changes Related to Risk-Benefit Profile in Pregnancy and Nursing Mothers, and
Update to Mechanism of Action Section
Company Also Announces Extension of sNDA Priority Review for AMITIZA
Submission Seeking Approval for Treatment of Opioid-Induced Constipation
BETHESDA, Md. -- November 30, 2012
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that the Company
received a supplement approval from the U.S. Food and Drug Administration
(FDA) that removes pregnancy “warnings and precautions” and clarifies
information regarding the use of AMITIZA^® (lubiprostone) by pregnant and/or
nursing women. In addition, the FDA expanded the labeling text of the
Mechanism of Action section in the prescribing information for AMITIZA.
AMITIZA is approved for the treatment of chronic idiopathic constipation (CIC)
in adults (24 mcg twice daily) and irritable bowel syndrome with constipation
(IBS-C) in women 18 years of age and older (8 mcg twice daily).
The Company also announced today that the FDA has extended the Prescription
Drug User Fee Act (PDUFA) goal date for the Agency’s priority review of the
supplemental new drug application (sNDA) filing seeking approval for an
additional indication for lubiprostone for the treatment of opioid-induced
constipation (OIC) in patients with chronic, non-cancer pain. Sucampo was
notified that its November 16, 2012 submission of FDA-requested supportive
analyses has been designated as a major amendment to the application. Since
the receipt date of this additional information is within three months of the
PDUFA date, the FDA has decided to extend the goal date by three months to
provide time for a full review of the submission. The extended user fee goal
date is late April, 2013. No new clinical trials or studies have been
requested by the FDA.
“Sucampo’s scientific and regulatory teams are pleased with the FDA-approved
changes to the AMITIZA label. We believe these changes will enable physicians
and women of child-bearing age who are suffering from IBS-C or CIC to better
evaluate the risk-benefit profile of AMITIZA. The details added to the
mechanism of action section highlight AMITIZA’s ability to restore the mucosal
barrier of the gut, which is important to further clarify clinician
understanding of how AMITIZA may work in the treatment of IBS-C. Additionally,
we look forward to completion of the FDA’s review of our sNDA for OIC,” said
Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of
Sucampo has accepted the following FDA-approved labeling changes, which will
be effective immediately:
1.All pregnancy-related Warnings and Precautions (Section 5.1 of the label)
have been removed. This includes deletion of the sentence: “Women who
could become pregnant should have a negative pregnancy test prior to
beginning therapy with AMITIZA and should be capable of complying with
effective contraceptive measures.”
2.Section 8 of the product labeling, “Use in Specific Populations,” was
updated to include additional animal data and a Clinical Consideration
section, with the pregnancy category remaining unchanged.
3.Previous labeling statements regarding the potential for serious adverse
reactions in nursing infants have been removed. The revised label states
that caution should be exercised when AMITIZA is administered to a nursing
mother and advises “lactating women to monitor their human milk-fed
infants for diarrhea while taking AMITIZA.”
4.The Mechanism of Action section (Section 12.1) of the label now reads as
follows: “Lubiprostone is a locally acting chloride channel
activator…activation of ClC-2 by lubiprostone has been shown to stimulate
recovery of mucosal barrier function and reduce intestinal permeability
(bolding added to indicate label addition) via the restoration of tight
junction complexes in ex vivo studies of ischemic porcine intestine.”
A recent study suggests that one of the contributing factors to abdominal pain
in IBS may be increased intestinal permeability induced by disruption of the
tight junctions. It has been previously established that activation of the
ClC-2 chloride channel specifically, but not CFTR chloride channel, mediates
reduction in intestinal permeability. Lubiprostone is the only product
approved for use in IBS-C which includes a mechanism of action for reducing
For further information please see the complete Prescribing Information and
About AMITIZA (lubiprostone) for Chronic Idiopathic Constipation (CIC) and
Irritable Bowel Syndrome with Constipation (IBS-C)
AMITIZA is a chloride channel activator indicated for the treatment of CIC (24
mcg twice daily) in adults and for IBS-C (8 mcg twice daily) in women 18 years
of age and older.
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 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 healthcare provider.
AMITIZA should not be prescribed to patients that have severe diarrhea.
Patients should be aware of the possible occurrence of diarrhea during
treatment and inform their healthcare provider if the diarrhea becomes severe.
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 healthcare
provider. 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 Chronic Idiopathic Constipation (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 (8 mcg twice daily vs placebo; N=1011 vs N=435,
respectively) in patients with Irritable Bowel Syndrome with Constipation
(IBS-C), the most common adverse reactions (incidence > 4%) were nausea (8% vs
4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).
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 patients with moderate and severe hepatic impairment.
Reduce the dosage in IBS-C patients with severe hepatic impairment.
For further information please see the complete Prescribing Information and
About Sucampo Pharmaceuticals
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, 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.
Sucampo Forward-Looking Statements
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
US and internationally and the exposure to litigation and/or regulatory
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 Form 10-K for the year ended Dec. 31, 2011, which the
Company incorporates by reference.
Sucampo Pharmaceuticals, Inc.
Silvia Taylor, 1-240-223-3718
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