Allergan Reports New Data Reinforcing the Effectiveness of Viberzi® (Eluxadoline) to Treat the Symptoms Associated with Irritable Bowel Syndrome with Diarrhea (IBS-D), Abdominal Pain and Diarrhea
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-- Viberzi® proven safe and effective in patients who reported inadequate response to prior loperamide use1 --
DUBLIN, July 10, 2017 /PRNewswire/ -- Allergan plc (NYSE:AGN) announced additional results of a prespecified prospective pooled subgroup analysis from the two Phase 3 studies (IBS-3001 and IBS-3002), which evaluated the efficacy and safety of Viberzi in nearly 2,500 IBS-D patients, of whom 36 percent reported use of loperamide in the 12 months prior to study randomization. These data demonstrate Viberzi® (eluxadoline) safely and effectively treats the IBS-D symptoms of abdominal pain and diarrhea irrespective of prior use of loperamide.1 These analyses also demonstrated efficacy and safety in patients with loperamide rescue medication use compared to the overall population during the two studies. The American Journal of Gastroenterology published these results, Eluxadoline Efficacy in IBS-D Patients Who Report Prior Loperamide Use, in the June issue.
"Irritable bowel syndrome with diarrhea is a health concern that affects approximately 16 million people,2,3 and despite the use of over-the-counter medications, many patients experience debilitating symptoms associated with the syndrome and often cycle through several options with little to no relief," said lead author Brian E. Lacy, MD, PhD, Division of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center. "These results further support the use of eluxadoline to provide significant and effective relief from abdominal pain and diarrhea, two of the most common symptoms affecting those suffering with IBS-D, regardless of prior treatment experience."
Among patients who reported prior loperamide use with inadequate symptom control, a significantly greater proportion of patients treated with eluxadoline were composite responders over weeks 1-12 compared with those treated with placebo (eluxadoline 100 mg: 27.0 percent (P<0.001) and 75 mg: 26.3 percent (P=0.001) versus placebo 12.7 percent). The most commonly reported adverse events (AEs) are consistent with the known safety profile of eluxadoline, which were nausea, abdominal pain, constipation and headache.1
"These results continue to build on the robust clinical profile that has already been established, and further underscores Viberzi® as a safe and effective treatment option for patients suffering from inadequate symptom control associated with a commonly used treatment for IBS-D," said David Nicholson, Ph.D., Chief Research & Development Officer, Allergan.
About Viberzi® (Eluxadoline)
Eluxadoline is marketed by Allergan in the United States as Viberzi® (eluxadoline) CIV. 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 acts locally in the gut and 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: https://www.allergan.com/assets/pdf/viberzi_pi.
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 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 or vomiting, associated with elevations of pancreatic enzymes or liver transaminases. Do not restart VIBERZI in patients who developed biliary duct obstruction while taking VIBERZI.
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 company and a leader in a new industry model – Growth Pharma. 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 with 70+ mid-to-late stage pipeline programs currently in development.
Allergan's success is powered by our more than 18,000 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 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; 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, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended March 31, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
Lacy, B. E., Chey, W. D., Cash, B. D., Lembo, A. J., Dove, L. S., & Covington, P. S. Eluxadoline Efficacy in IBS-D Patients Who Report Prior Loperamide Use. The American Journal of Gastroenterology. 2017 Apr; 112(4).
2
Grundmann O, Yoon SL. Irritable bowel syndrome: epidemiology, diagnosis and treatment: an update for health-care practitioners. J Gastroenterol Hepatol. 2010 Apr;25(4):691-9.
3
US Census Bureau. USA QuickFacts from the US Census Bureau. Available at https://www.census.gov/quickfacts. Accessed October 27, 2016
