DUBLIN, Oct. 8, 2018 /PRNewswire/ -- Allergan, Inc. (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
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, 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.
- 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, 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.
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.
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.
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