Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ:SCMP), a global
biopharmaceutical company, today announced that the U.S. Food and
Drug Administration (FDA) has accepted for filing its recently
submitted supplemental New Drug Application (sNDA) for lubiprostone
(AMITIZA®) in children aged 6 to 17 years with pediatric functional
constipation. The filing has received Priority Review
designation from the FDA.
Priority Review status is designated for drugs that may offer
major advances in treatment or provide a treatment where no
adequate therapy exists. The granting of Priority Review
status accelerates the timing of the FDA review of the sNDA
application. The FDA has assigned a user fee goal date of
January 28, 2018.
“We are pleased with the FDA’s acceptance of the sNDA filing
with Priority Review, as this underscores the need for prescription
options for children 6 to 17 years of age suffering from pediatric
functional constipation,” said Peter Greenleaf, Chairman and Chief
Executive Officer of Sucampo. “If approved, AMITIZA would be
the first and only prescription medication specifically for these
pediatric patients, who currently have limited options to address
their underlying functional constipation.”
Earlier this week Sucampo also announced that a Phase 3 study to
evaluate the bioequivalence of sprinkle and capsule formulations of
lubiprostone (AMITIZA®) as compared to placebo in adult subjects
with chronic idiopathic constipation (CIC) did not show
bioequivalence, but did demonstrate significant activity and was
well-tolerated. Sucampo’s focus continues to be on the
potential approval of the pediatric indication and will not be
moving forward with an NDA submission for the sprinkle formulation
in adults. Sucampo will continue to have discussions with the
FDA in the coming months about the ongoing pediatric functional
constipation program in younger children ages 6 months through 5
years of age.
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 opioid induced constipation (OIC)
with chronic, non-cancer pain, including chronic pain related to
prior cancer or its treatment who do not require frequent (e.g.
weekly) opioid dose escalation. The effectiveness in patients
with OIC taking diphenylheptane opioids (e.g. methadone) has not
been established. AMITIZA (8 mcg twice daily) is also
approved in the U.S. for irritable bowel syndrome with constipation
(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).
AMITIZA is also approved in select other markets for
constipation indications.
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. Concomitant
administration of food with AMITIZA may reduce symptoms of
nausea.
Avoid use of AMITIZA in patients with severe diarrhea. Patients
should be aware of the possible occurrence of diarrhea during
treatment. Instruct patients to discontinue AMITIZA and contact
their HCP if severe diarrhea occurs.
Syncope and hypotension have been reported with AMITIZA in the
postmarketing setting and a few of these adverse reactions resulted
in hospitalization. Most reports occurred in patients taking 24 mcg
twice daily. Patients should be aware that the risk of syncope and
hypotension may be increased with concomitant diarrhea, vomiting,
or use of medications known to lower blood pressure. Inform
patients that syncope and hypotension may occur within an hour of
the first dose or subsequent doses of AMITIZA and generally resolve
prior to the next dose, but may recur with repeat dosing. Instruct
patients to discontinue AMITIZA and contact their HCP if these
reactions occur.
Dyspnea may occur within an hour of first dose. This symptom
generally resolves within three hours, but may recur with repeat
dosing. Instruct patients to contact their HCP if dyspnea occurs.
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.
About Sucampo Pharmaceuticals,
Inc.
Sucampo Pharmaceuticals, Inc. is a biopharmaceutical company
focused on the development and commercialization of highly
specialized medicines. Sucampo has a late-stage pipeline of product
candidates in clinical development for orphan disease areas,
including VTS-270, a mixture of 2-hydroxypropyl-B-cyclodextrins
with a specific compositional fingerprint that has been granted
orphan designation in the U.S. and Europe and is in a pivotal Phase
2/3 clinical trial for the treatment of Niemann-Pick Disease Type
C-1, a rare progressive genetic disorder. VTS-270 has also been
granted breakthrough therapy designation in the U.S. Sucampo has an
exclusive option for the North American rights to CPP-1X/sulindac,
which is in Phase 3 development for the treatment of familial
adenomatous polyposis and has been granted orphan drug designation
in the U.S. The company has two marketed products – AMITIZA and
RESCULA. 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 financial results, product
development, 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; Sucampo’s ability to successfully integrate the
operations of acquired businesses; dependence on the effectiveness
of Sucampo's patents and other protections for innovative products;
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
press release 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 8, 2017, 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:
Sucampo Pharmaceuticals, Inc.Silvia TaylorSenior Vice President,
Investor Relations and Corporate
Affairs1-240-223-3718staylor@sucampo.com
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