AMITIZA(R) (Lubiprostone) Receives NICE Recommendation
BETHESDA, Md., June 17, 2014 (GLOBE NEWSWIRE) -- Sucampo
Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global
biopharmaceutical company, today announced that the United Kingdom's
(U.K.) National Institute of Health and Care Excellence (NICE) has
released a Final Appraisal Determination with guidance for the
recommendation of the use of AMITIZA(R) (lubiprostone) in the treatment
of chronic idiopathic constipation (CIC) and associated symptoms in
adults who have failed laxatives.
Constipation is characterized by infrequent and difficult passage of
stool and becomes chronic when a person suffers specified symptoms
(such as, but not limited to, straining, hard stools, and sensation of
incomplete evacuation) for a period of three months with symptom onset
at least six months prior to diagnosis.1 Chronic constipation is
idiopathic if it is not caused by other diseases or by the use of
medications. CIC is a debilitating condition that affects millions
worldwide with an estimated 300,000 patients under the care of a
general practitioner in the U.K.2-3 and approximately 84,000 who have
failed two previous laxatives.3 Of these, one-third are men for which
there are currently few products broadly reimbursed in the U.K.4
"With more than eight million prescriptions dispensed globally over the
past eight years, AMITIZA has demonstrated to be an effective treatment
option with a well-tolerated safety profile, and we believe in the
value AMITIZA offers to CIC patients in the U.K. who are unresponsive
to the treatments that are currently available," stated Peter
Greenleaf, Chief Executive Officer of Sucampo. "We are pleased by the
NICE recommendation as this will make AMITIZA more widely accessible to
patients in the U.K. who may benefit from it, thus continuing our
mission of meeting unmet patient needs on a global basis."
This guidance by NICE's appraisal committee recommends lubiprostone as
an option for the treatment of patients who are considered to be the
most difficult to treat, having failed at least two previous laxatives
at maximum tolerated doses for a period of six months, and for whom
invasive procedures are being considered.
"Constipation places a significant burden on the U.K. healthcare
system, resulting in over 60,000 hospitalizations annually5," said Dr.
Ramesh Arasaradnam, University Hospitals Coventry and Warwickshire NHS
Trust and University of Warwick. "For many of the patients who are
refractory to standard laxatives, effectively treating with
lubiprostone in primary care could negate the need to progress to a
secondary or tertiary care referral."
According to June Rogers, MBE, Team Director of PromoCon*, "Chronic
constipation has a detrimental impact on the quality of life of
thousands of patients, particularly in the elderly. PromoCon is
delighted that this guidance recognizes the burden of chronic
constipation, as we believe that providing innovative medicines in
primary care will improve the healthcare of CIC patients."
AMITIZA was approved by the Medicines and Healthcare Products
Regulatory Agency in September 2012 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, and was made commercially available in the
U.K. in December 2013.
For the full guidance from NICE on the usage of AMITIZA in the U.K.,
please visit here.
About AMITIZA (lubiprostone)
AMITIZA (lubiprostone) is a prostone, a locally acting chloride channel
activator, indicated in the United States for the treatment of CIC (24
mcg twice daily) 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
in the U.S. for irritable bowel syndrome with constipation (8 mcg twice
daily) in women 18 years of age and older in the U.S. 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 in adults.
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
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 see the Full Prescribing Information here. For further
information on AMITIZA, please visit www.sucampo.com/products.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is focused on the discovery, development
and commercialization of drugs based on ion channel activators known as
prostones. Prostones are naturally occurring fatty acid metabolites
with unique physiological activities. Sucampo has two marketed products
- AMITIZA(R) 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,
Switzerland and the U.K. For more information, please visit
www.sucampo.com.
The Sucampo logo is the registered trademark and the tagline, The
Science of Innovation, is a pending trademark 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.
Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo
Pharmaceuticals).
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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 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.
*PromoCon provides a national service, working as part of Disabled
Living, Manchester to improve the life for all people with bladder or
bowel problems by offering product information, advice and practical
solutions to both professionals and the general public.
References:
1. Rome Foundation. Rome III Diagnostic Criteria for Functional
Gastrointestinal Disorders. Available at:
http://www.romecriteria.org/assets/pdf/19_RomeIII_apA_885-898.pdf.
Accessed 28 May 2014.
2. National Horizon Scanning Centre. Prucalopride (Resolor) for chronic
constipation Birmingham: National Horizon Scanning Centre (NHSC).
Horizon Scanning Technology Briefing. 2008.
3. Shafe AC. The LUCK study: Laxative Usage in patients with
GP-diagnosed Constipation in the UK, within the general population and
in pregnancy. An epidemiological study using the General Practice
Research Database (GPRD). Therap Adv Gastroenterol. (2011) 4(6):
343-363.
4. Muller-Lissner S, Tack J, Feng Y, et al. (2013) Levels of
satisfaction with current chronic constipation treatment options in
Europe - an internet survey. Aliment Pharmacol Ther. 37(1): 137-145.
5. Hospital Episode Statistics 2012/13: Admitted Patient Care. November
2013.
CONTACT: Sucampo Pharmaceuticals, Inc.
Silvia Taylor
Senior Vice President, Investor Relations
and Corporate Communications
1-240-223-3718
[email protected]
For U.K. and European Media Inquiries:
Creston Health
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