Allergan Announces U.S. Availability of VIBERZI™ (eluxadoline) for Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) in Adults

DUBLIN, Dec. 14, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced today that VIBERZI™ (eluxadoline), the company's first-in-class treatment for irritable bowel syndrome with diarrhea (IBS-D), is now available by prescription in the U.S.

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"We are excited about the launch of VIBERZI, which addresses an unmet need among IBS-D patients seeking a treatment to manage their symptoms proactively," said William Meury, President and Executive Vice President, Branded Pharma at Allergan. "This introduction reaffirms Allergan's commitment to providing a new treatment option that serves to help gastroenterologists reach better outcomes for their patients."

IBS-D is a multifactorial disorder marked by recurrent abdominal pain or discomfort and diarrhea that affects as many as 15 million adult Americans, impacting both women and men equally.^{[i],[ii],[iii]} There are few prescription treatment options available for IBS-D, particularly options that relieve both the diarrhea and abdominal pain associated with IBS-D.

VIBERZI is an oral medication that relieves the core symptoms of IBS-D, diarrhea and abdominal pain. Symptom relief was maintained throughout treatment in two pivotal clinical trials.

On November 12, 2015, the Drug Enforcement Agency (DEA) completed its review of VIBERZI (eluxadoline), and published its Final Rule placing VIBERZI into Schedule IV of the Controlled Substance Act. Schedule IV drugs, substances, or chemicals are defined by the DEA as drugs with a low potential for abuse and low risk of dependence.^[iv]

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 (pronounced vye-BER-zee) is an orally active compound indicated 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 receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.^[v]

IMPORTANT SAFETY INFORMATION

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 (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.

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 at http://www.actavis.com/Actavis/media/PDFDocuments/VIBERZI_PI.pdf

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

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 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.

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 June 30, 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.

^[i] Camilleri M. Current and future pharmacological treatments for diarrhea-predominant irritable bowel syndrome. Expert Opinion on Pharmacotherapy. 2013;14:1151.
^[ii] Grundmann O, Yoon SL. Irritable bowel syndrome: epidemiology, diagnosis, and treatment: an update for health-care practitioners. Journal of Gastroenterology and Hepatology. 2010;25:691–699.
^[iii] Eluxadoline Xifaxin Summary Final. November 2014.
^[iv] Drug Scheduling. United States Drug Enforcement Agency. http://www.dea.gov/druginfo/ds.shtml. Accessed December 3, 2015.
^[v] IBS in the Real World Survey (2002): 8. International Foundation for Functional Gastrointestinal Disorders, Aug. 2002. Web. 29 Apr. 2015.

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SOURCE Allergan plc

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