DUBLIN, Oct. 14, 2016 /PRNewswire/ -- Allergan plc
(NYSE: AGN), a leading global pharmaceutical company committed to
the research and development of new treatments for gastrointestinal
diseases, today announced that new data from its irritable bowel
syndrome portfolio will be featured in two poster presentations at
the upcoming American College of Gastroenterology (ACG) Annual
Scientific Meeting in Las Vegas,
NV, October 14-19,
2016.
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The scheduled times (noted in local Pacific Time) of the three
VIBERZI® (eluxadoline) presentations in the exhibit hall at The
Venetian Hotel are as follows:
- Efficacy and Safety of Eluxadoline in IBS-D Patients Who Report
Prior Inadequate Symptom Control with Loperamide
Date and Time: Monday, October
17, 10:30 AM – 4:00 PM
Poster Number: P1123
Category: Functional Bowel Disease
- Impact of Baseline Pain Severity on the Efficacy of Eluxadoline
in Patients with Irritable Bowel Syndrome with Diarrhea
Date and Time: Tuesday, October
18, 10:30 AM – 4:00 PM
Poster Number: P1876
Category: Functional Bowel Disease
About VIBERZI
VIBERZI (eluxadoline) is a twice daily, oral medication
indicated for use in adults suffering from irritable bowel syndrome
with diarrhea (IBS-D).
VIBERZI is an orally active compound indicated for the treatment
of IBS-D in men and women that acts locally in the gut.
IMPORTANT SAFETY INFORMATION FOR VIBERZI
Contraindications
VIBERZI is contraindicated for patients
with:
- Known or suspected biliary duct obstruction, or sphincter of
Oddi disease or dysfunction; a history of pancreatitis; structural
diseases of the pancreas.
- Alcoholism, alcohol abuse, alcohol addiction, or drink more
than 3 alcoholic beverages per day.
- Severe hepatic impairment.
- A history of chronic or severe constipation or sequelae from
constipation, or known or suspected mechanical gastrointestinal
obstruction.
Warnings and Precautions
Sphincter of Oddi
Spasm:
- There is a potential for increased risk of sphincter of Oddi
spasm, resulting in pancreatitis or hepatic enzyme elevation
associated with acute abdominal pain (e.g., biliary-type pain) with
VIBERZI. These events were reported in less than 1% of patients
receiving VIBERZI in clinical trials.
- Patients without a gallbladder are at increased risk. Consider
alternative therapies before using VIBERZI in patients without a
gallbladder and evaluate the benefits and risks of VIBERZI in these
patients.
- Inform patients without a gallbladder that they may be at
increased risk for symptoms of sphincter of Oddi spasm, such as
elevated liver transaminases associated with abdominal pain or
pancreatitis, especially during the first few weeks of treatment.
Instruct patients to stop VIBERZI and seek medical attention if
they experience symptoms of sphincter of Oddi spasm.
Pancreatitis:
- There is a potential for increased risk of pancreatitis not
associated with sphincter of Oddi spasm; such events were reported
in less than 1% of patients receiving VIBERZI in clinical trials,
and the majority were associated with excessive alcohol intake. All
pancreatic events resolved upon discontinuation of VIBERZI.
- Instruct patients to avoid chronic or acute excessive alcohol
use while taking VIBERZI. Monitor for new or worsening abdominal
pain that may radiate to the back or shoulder, with or without
nausea and vomiting, associated with elevations of pancreatic
enzymes. Instruct patients to stop VIBERZI and seek medical
attention if they experience symptoms suggestive of
pancreatitis.
Adverse Reactions
- The most commonly reported adverse reactions (incidence >5%
and greater than placebo) were constipation, nausea, and abdominal
pain.
Please also see full Prescribing Information for
VIBERZI.
For more information, including full prescribing
information about VIBERZI, visit
http://www.allergan.com/assets/pdf/viberzi_pi
About IBS-D
Irritable bowel syndrome with diarrhea
(IBS-D) is a functional bowel disorder characterized by chronic
abdominal pain and frequent diarrhea, which affects approximately
15 million patients in the U.S. Although the exact cause of IBS-D
is not known, symptoms are thought to result from a disturbance in
the way the gastrointestinal tract and nervous system interact.
IBS-D can be debilitating and there are limited therapeutic
options for managing the chronic symptoms. IBS-D is associated with
economic burden in direct medical costs and indirect social costs
such as absenteeism and lost productivity, along with decreased
quality of life.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin,
Ireland, is a bold, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing branded pharmaceuticals, devices
and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and
best-in-class products for the central nervous system, eye care,
medical aesthetics and dermatology, gastroenterology, women's
health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the
Company's R&D model, which defines our approach to identifying
and developing game-changing ideas and innovation for better
patient care. This approach has led to Allergan building
one of the broadest development pipelines in the pharmaceutical
industry with 65+ mid-to-late stage pipeline programs in
development.
Our Company's success is powered by our more than 16,000 global
colleagues' commitment to being Bold for Life. Together, we build
bridges, power ideas, act fast and drive results for our customers
and patients around the world by always doing what is right.
With commercial operations in approximately 100
countries, Allergan is committed to working with
physicians, healthcare providers and patients to deliver innovative
and meaningful treatments that help people around the world live
longer, healthier lives.
For more information, visit Allergan's website
at www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective of existing trends
and information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements. Actual
results may differ materially from Allergan's current
expectations depending upon a number of factors
affecting Allergan's business. These factors include,
among others, the risks associated with acquisition transactions;
the difficulty of predicting the timing or outcome of FDA
approvals or actions, if any; the impact of competitive products
and pricing; market acceptance of and continued demand
for Allergan's products; difficulties or delays in
manufacturing; and other risks and uncertainties detailed
in Allergan's periodic public filings with
the Securities and Exchange Commission, including but not
limited to Allergan's Quarterly Report on Form 10-Q for
the quarter ended December 31, 2015 (such periodic public
filings having been filed under the "Actavis plc" name) and from
time to time in Allergan's other investor communications.
Except as expressly required by law, Allergan disclaims
any intent or obligation to update these forward-looking
statements.
CONTACTS:
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Investors:
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Lisa
DeFrancesco
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(862)
261-7152
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Media:
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Mark
Marmur
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(862)
261-7558
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Fran
DeSena
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(973)
517-3132
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SOURCE Allergan plc