Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global
biopharmaceutical company, today announced that the United
Kingdom's National Institute of Health and Care Excellence (NICE)
has published the technology appraisal guidance recommending the
use of AMITIZA® (lubiprostone) in the treatment of chronic
idiopathic constipation (CIC) and associated symptoms in adults who
have failed laxatives.
The NICE guidance recommends AMITIZA as an option for treating
CIC for adults in whom treatment with at least 2 laxatives from
different classes, at the highest tolerated recommended doses for
at least 6 months, has failed to provide adequate relief and for
whom invasive treatment for constipation is being considered.
"We are pleased that NICE has published its recommendation for
AMITIZA today, as this will make AMITIZA more widely accessible to
patients in the U.K. who may benefit from it," stated Peter
Greenleaf, Chief Executive Officer of Sucampo. "Through more than
eight years of experience and eight million prescriptions dispensed
globally, AMITIZA has been demonstrated to be an effective
treatment option with a well-tolerated safety profile. Today's NICE
recommendation for AMITIZA is an important step in allowing us to
fulfill Sucampo's mission of meeting unmet patient needs in the
U.K., and on a global basis."
NICE regulations require that clinical commissioning groups,
National Health Service England and local authorities comply with
NICE recommendations within three months of the date of
publication. Specifically, the NICE guidance for AMITIZA
states that "if a patient has chronic idiopathic constipation and
the doctor responsible for their care thinks that lubiprostone is
the right treatment, it should be available for use, in line with
NICE's recommendations."1
"Constipation places a significant burden on the U.K. healthcare
system, resulting in over 60,000 hospitalizations annually,"2 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 http://www.nice.org.uk/guidance/TA318
About Chronic Idiopathic Constipation
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.3 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.4-5 and approximately 84,000 who have failed two
previous laxatives.5 Of these, one-third are men for which there
are currently few products broadly reimbursed in the U.K.6
About AMITIZA (lubiprostone)
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.
Important Safety Information (U.K.)
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
diarrhoea. Patients should be aware of the possible occurrence of
diarrhoea during treatment. Patients should be instructed to inform
their physician if severe diarrhoea 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.
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 medicines to meet the major
unmet medical needs of patients on a global basis. Sucampo has two
marketed products – AMITIZA® and RESCULA® – and a pipeline of
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. National Institute for Health and Care Excellence Technology
Appraisal Guidance 318, "Lubiprostone for treating chronic
idiopathic constipation." Issued: July 2014.
2. Hospital Episode Statistics 2012/13: Admitted Patient Care.
November 2013.
3. 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.
4. National Horizon Scanning Centre. Prucalopride (Resolor) for
chronic constipation Birmingham: National Horizon Scanning Centre
(NHSC). Horizon Scanning Technology Briefing. 2008.
5. 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.
6. 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.
CONTACT: Sucampo Pharmaceuticals, Inc.
Silvia Taylor
Senior Vice President, Investor Relations and Corporate Communications
1-240-223-3718
staylor@sucampo.com
For U.K. and European Media Inquiries:
Creston Health
Lolita McGee, Danielle Guildford-Sharp or Kim Lemon
+44-(0)-20-8747-2099
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