DUBLIN, Oct. 8, 2018 /PRNewswire/ -- Allergan
plc (NYSE: AGN), a leading global pharmaceutical company,
today announced it will present data from its gastroenterology
portfolio at the American College of Gastroenterology Annual
Scientific Meeting (ACG), from October 5-10,
2018 in Philadelphia,
PA.
"Allergan is working to change treatment paradigms across
gastroenterology with our Open Science research and development
model," said David Nicholson, Chief Research and
Development Officer, Allergan. "We are committed to uncovering
the full potential of our approved medicines as well as
collaborating with leading researchers to advance the
investigational therapies in our pipeline. We look forward to
showcasing our latest research to gastroenterologists at this
important annual meeting."
Allergan will present efficacy and safety data from RELIEF, a
Phase 4, multicenter, multinational, randomized,
placebo-controlled, double-blind study of VIBERZI®
(eluxadoline) CIV in patients with irritable bowel syndrome with
diarrhea (IBS-D) who report inadequate symptom control with
loperamide (poster #0344).
Allergan will also present data on two investigational drugs,
which include:
- Long-Term Safety in the Open-Label Period of a Phase 2a Study
of Brazikumab, an Antibody Against Interleukin-23 (poster
#0451)
- Overall Safety and Tolerability of Relamorelin in Adults with
Diabetic Gastroparesis: Analysis of Phase 2a and Phase 2b Trial Data (poster #1709)
About VIBERZI® (eluxadoline)
Eluxadoline is marketed by Allergan in the United States as VIBERZI®.
VIBERZI® is a twice daily, oral medication used to treat
adults with irritable bowel syndrome with diarrhea (IBS-D).
VIBERZI® has mixed opioid receptor modulator activity;
it is a mu- and kappa-opioid receptor agonist and a delta-opioid
receptor antagonist. VIBERZI® is thought to decrease
visceral hypersensitivity and control GI motility, based on
nonclinical studies. VIBERZI® is indicated for the
treatment of IBS-D in adult men and women. Please also see
full Prescribing Information.
IMPORTANT SAFETY INFORMATION
Contraindications
VIBERZI is contraindicated in
patients:
- Without a gallbladder.
- With known or suspected biliary duct obstruction, or sphincter
of Oddi disease or dysfunction; a history of pancreatitis; or
structural diseases of the pancreas.
- With alcoholism, alcohol abuse, alcohol addiction, or who drink
more than 3 alcoholic beverages per day.
- With a known hypersensitivity reaction to VIBERZI.
- With severe hepatic impairment.
- With a history of chronic or severe constipation or sequelae
from constipation, or known or suspected mechanical
gastrointestinal obstruction.
Warnings and Precautions
Pancreatitis:
- Pancreatitis, with or without sphincter of Oddi spasm, has been
reported in patients taking either the 75 mg or 100 mg dosage of
VIBERZI, including serious cases resulting in hospitalization,
primarily in patients without a gallbladder. Fatal cases have also
been reported in patients without a gallbladder. VIBERZI is
contraindicated in patients without a gallbladder. Most of the
reported cases of serious pancreatitis occurred within a week of
starting treatment with VIBERZI and some patients developed
symptoms after one to two doses.
- In patients with a gallbladder, evaluate a patient's alcohol
intake prior to starting 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. Instruct
patients to immediately stop VIBERZI and seek medical attention if
they experience symptoms suggestive of pancreatitis such as acute
abdominal or epigastric pain radiating to the back or shoulder
associated with elevations of pancreatic enzymes with or without
nausea and vomiting.
Sphincter of Oddi Spasm:
- There is a risk of sphincter of Oddi spasm, resulting in
pancreatitis or hepatic enzyme elevation associated with acute
abdominal pain (eg, biliary-type pain) in patients taking VIBERZI.
Serious adverse reactions of sphincter of Oddi spasm with or
without pancreatitis resulting in hospitalization have been
reported, primarily in patients without a gallbladder. Cases of
serious sphincter of Oddi spasm occurred within a week of starting
treatment with VIBERZI and some patients developed symptoms after
one to two doses.
- Instruct patients to immediately stop VIBERZI and seek medical
attention if they experience symptoms suggestive of sphincter of
Oddi spasm such as acute worsening of abdominal pain that may
radiate to the back or shoulder with or without nausea and
vomiting, associated with elevations of pancreatic enzymes or liver
transaminases. Do not restart VIBERZI in patients who developed
biliary duct obstruction while taking VIBERZI.
Hypersensitivity Reactions:
- In postmarketing experience, serious hypersensitivity reactions
(including anaphylaxis) have been reported following VIBERZI
administration. Some of these reactions occurred after the first
one or two doses of VIBERZI.
- Instruct patients to immediately stop VIBERZI and seek medical
attention if they experience symptoms suggestive of a
hypersensitivity reaction.
Constipation:
- Constipation, sometimes requiring hospitalization, has been
reported following VIBERZI administration. In postmarketing
experience, severe cases with development of intestinal
obstruction, intestinal perforation, and fecal impaction, requiring
intervention, have also been reported. Instruct patients to stop
VIBERZI and immediately contact their healthcare provider if they
experience severe constipation. Avoid use with other drugs that may
cause constipation.
Adverse Reactions
The most commonly reported adverse
reactions (incidence >5% and greater than placebo) were
constipation, nausea, and abdominal pain.
About Allergan plc
Allergan plc (NYSE: AGN),
headquartered in Dublin, Ireland, is a bold, global pharmaceutical
leader. Allergan is focused on developing, manufacturing and
commercializing branded pharmaceutical, device, biologic, surgical
and regenerative medicine 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, a
model of research and development, which defines our approach to
identifying and developing game-changing ideas and innovation for
better patient care. With this approach, Allergan has
built one of the broadest development pipelines in the
pharmaceutical industry.
Allergan's success is powered by our 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 every day.
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 on existing trends and
information as of the date of this release. 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 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; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; risks associated with
divestitures, acquisitions, mergers and joint ventures; uncertainty
associated with financial projections, debt reduction, projected
cost reductions, projected synergies, restructurings, increased
costs, and adverse tax consequences; 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 Annual Report
on Form 10-K for the year ended December 31,
2017 and Allergan's Quarterly Report on Form 10-Q for the
period ended June 30, 2018. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
CONTACTS: Allergan
Investors:
Daphne Karydas
(862) 261-8006
Karina Calzadilla
(862) 261-7328
Media:
Amy Rose
(862) 289-3072
Sara Bosco
(862) 261-8130
View original content to download
multimedia:http://www.prnewswire.com/news-releases/allergan-presents-new-research-at-the-american-college-of-gastroenterology-annual-scientific-meeting-acg-2018-300725562.html
SOURCE Allergan plc