Allergan Announces U.S. Availability of VIBERZI™ (eluxadoline) for Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) in Adults
December 14, 2015
DUBLIN, Dec. 14, 2015 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:
Warnings and Precautions
Sphincter of Oddi Spasm:
Pancreatitis:
Adverse Reactions
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.
AboutAllergan
Allergan plc(NYSE: AGN), headquartered inDublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma.Allerganis focused on developing, manufacturing and commercializing innovative branded pharmaceuticals and biologic products for patients around the world.
Allerganmarkets 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.Allerganis 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,Allerganis 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, visitAllergan'swebsite atwww.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 reflectAllergan'scurrent perspective of existing trends and information as of the date of this release. Except as expressly required by law,Allergandisclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially fromAllergan'scurrent expectations depending upon a number of factors affectingAllergan'sbusiness. These factors include, among others, the risks associated with acquisition transactions; the difficulty of predicting the timing or outcome ofFDAapprovals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand forAllergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed inAllergan'speriodic public filings with theSecurities and Exchange Commission, including but not limited toAllergan'sQuarterly Report on Form 10-Q for the quarter endedJune 30, 2015(such periodic public filings having been filed under the "Actavis plc" name) and from time to time inAllergan'sother investor communications. Except as expressly required by law,Allergandisclaims 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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