DGAP-News: Sucampo Pharmaceuticals, Inc. /
Sucampo Receives Notice that Second Indication for AMITIZA for
Opioid-Induced Constipation Is Not Approved by Medicines and
Healthcare Products Regulatory Agency in U.K.
13.03.2014 / 01:00
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Sucampo Will Evaluate All Options for Path Forward
BETHESDA, Md., 2014-03-13 01:00 CET (GLOBE NEWSWIRE) --
Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP) today announced that
Sucampo Pharma Europe, Ltd., its wholly owned subsidiary, has received a notice
of refusal to grant a Type II variation for AMITIZA(r) (lubiprostone) 24 mcg for
opioid- induced constipation (OIC) from the Medicines and Healthcare Products
Regulatory Agency (MHRA) in the United Kingdom (U.K.). In 2012, the MHRA
approved AMITIZA for the treatment of chronic idiopathic constipation (CIC) and
associated symptoms in adults when response to diet and other
non-pharmacological measures (e.g., educational measures, physical activity)
are inappropriate. In 2013, the United States (U.S.) Food and Drug
Administration approved AMITIZA as the first and only oral medication for the
treatment of OIC in adult patients with chronic, non-cancer pain. Sucampo is
reviewing the variation assessment report (VAR) from the MHRA and intends to
explore all available options for a path forward.
Sucampo completed in 2013 a Type II variation submission to update the Summary
of Product Characteristics (SPC) for AMITIZA in the U.K. to include the
additional therapeutic indication of OIC in non-cancer pain. MHRA is of the
opinion that insufficient evidence of efficacy for the proposed OIC indication
had been presented. The MHRA stated in the VAR that the safety profile of
lubiprostone appears consistent with what is currently described in the SPC for
the approved indication in CIC.
'While we are disappointed with the MHRA decision, we believe in the potential
of AMITIZA to meet the unmet medical needs of OIC patients,' said Peter
Greenleaf, Sucampo's Chief Executive Officer. 'AMITIZA is an important
treatment option for patients on three continents, with more than 8 million
patients treated in its 8 years on the market. Backed by the approval of
AMITIZA for OIC in the United States in 2013, we remain fully committed to
making AMITIZA available for additional indications in the U.K. and in other
geographic markets around the world. Sucampo intends to work closely with the
MHRA to determine our path forward.'
While the MHRA application included data from the comprehensive, global,
multi-study clinical development program for AMITIZA in OIC, which included
approximately 1,300 patients across 3 placebo-controlled Phase 3 trials
conducted in 7 countries including the U.K., the MHRA considered only one of
the studies to be pivotal.
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 decreases both muscle
motility and secretion of electrolytes, such as chloride, and causes subsequent
reduction in small intestinal fluid. 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.
About lubiprostone (AMITIZA)
AMITIZA (lubiprostone) is a prostone, a locally acting chloride channel
activator, indicated in the U.S. for the treatment of CIC (24 mcg twice daily)
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 in the U.S. for
irritable bowel syndrome with constipation (8 mcg twice daily) 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.
Important Safety Information - United States
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 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 visit www.sucampo.com/products for complete Prescribing Information and
for further information.
Important Safety Information - United Kingdom
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 lubiprostone treatment.
There are no or limited data from the use of lubiprostone in pregnant women.
Patients who become pregnant or are planning a pregnancy should be advised to
consider the risks and benefits of continued AMITIZA therapy during pregnancy.
Nausea is the most commonly reported adverse drug reaction observed in pivotal
clinical studies of AMITIZA, with 23.6% of patients experiencing at least one
treatment related nausea event; however, of those patients, 93% reported only a
single event during treatment with AMITIZA. Of all reported nausea events,
93.7% were mild to moderate in severity, and 4.0% discontinued treatment as a
result of nausea. Administration of AMITIZA with food has been shown to reduce
symptoms of nausea.
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 inform their physician if severe
diarrhea occurs.
Dyspnea or chest discomfort/pain (usually described as a sensation of chest
tightness and/or difficulty taking in a breath) has been reported shortly after
taking AMITIZA, and some patients have discontinued treatment. These symptoms
generally resolve within a few hours of dosing, but recurrence has been
frequently reported with subsequent doses. If these symptoms occur, the patient
should seek medical advice before resuming treatment.
In CIC, the safety of AMITIZA has been investigated in 301 patients in 3
pivotal clinical studies. During the pivotal clinical studies conducted on
AMITIZA, a number of ADRs have been reported. The most common ADR reported by
patients taking AMITIZA was nausea, with diarrhoea and headache also being
commonly reported. Treatment-emergent adverse events led to premature study
discontinuation for 8% of patients in the pivotal clinical studies.
Please visit http://www.amitiza.co.uk for complete Prescribing Information and
for further information.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is focused on the discovery, development and
commercialization of drugs based on ion channel activators knows as prostones.
Discovered by the company's scientific co-founder, Ryuji Ueno, M.D., Ph.D.,
Ph.D., prostones are naturally occurring fatty acid metabolites with unique
physiological activities. Sucampo has two marketed products - AMITIZA and
RESCULA(r) - and a pipeline of prostone-based product candidates in clinical
development. A global company, Sucampo is headquartered in Bethesda, Maryland,
and has operations in Japan, the United Kingdom and Switzerland. 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.
RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to
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.
Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo
Pharmaceuticals).
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LinkedIn
CONTACT: Silvia Taylor
Senior Vice President, Investor Relations
and Corporate Communications
1-240-223-3718
staylor@sucampo.com
News Source: NASDAQ OMX
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Language: English
Company: Sucampo Pharmaceuticals, Inc.
United States
ISIN: US8649091068
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257267 13.03.2014
DGAP-News: Sucampo Receives Notice that Second Indication for AMITIZA for Opioid-Induced Constipation Is Not Approved by Medicines and Healthcare Products Regulatory Agency in U.K.
| Source: EQS Group AG