Allergan plc today announced that three data posters/presentations for eluxadoline will be presented during the American College of Gastroenterology 2015 Annual Scientific Meeting in Honolulu, HI, October 16-21, 2015. The presentations will feature data from eluxadoline’s Phase III clinical trials in irritable bowel syndrome with diarrhea (IBS-D). VIBERZI™ (eluxadoline) was approved by the FDA on May 27, 2015 for the treatment of adults with IBS-D and is currently awaiting DEA scheduling.
Eluxadoline Demonstrates Efficacy for the Treatment of Irritable Bowel Syndrome (IBS) With Diarrhea (IBS-D) Among Multiple Clinically Relevant Patient Subgroups Monday, October 19, 10:00am – 3:30pm HST
Effect of Eluxadoline on Abdominal and Bowel Symptoms Over Time in Phase 3 Clinical Trials in Patients With Irritable Bowel Syndrome With Diarrhea
Tuesday, October 20, 9:30am – 3:30pm HST
Adverse Event Profile of Eluxadoline Over Time in Patients With Irritable Bowel Syndrome With Diarrhea
VIBERZI is an orally active compound for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in men and women. VIBERZI (eluxadoline) has mixed opioid receptor activity: it is a mu and kappa opioid receptor agonist, and a delta opioid receptor antagonist. The mixed opioid activity is designed to treat the symptoms of IBS-D while reducing the risk of constipation that can occur with unopposed mu-opioid receptor agonists.
IMPORTANT SAFETY INFORMATION
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 (eg, 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.
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.
The most commonly reported adverse reactions (incidence >5% and greater than placebo) were constipation, nausea, and abdominal pain.
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.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines.
Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
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.