Allergan Announces Partnership with Amy Dixon, Elite Paratriathlete, to Improve Patient-Physician Conversations About Irritable Bowel Syndrome with Diarrhea (IBS-D)

DUBLIN, Nov. 16, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced a national partnership with Amy Dixon, world champion paratriathlete and irritable bowel syndrome with diarrhea (IBS-D) patient. Through this partnership, Dixon will serve as a spokesperson to share her story with fellow IBS-D sufferers and healthcare providers, with the goal of improving dialogue between patients and their physicians about this condition and impact on patients' lives.

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IBS-D is a chronic gastrointestinal disorder, marked by recurrent abdominal pain and diarrhea, that affects as many as 16 million adult Americans and impacts roughly the same number of women and men.^1,2,3,4

"I experienced abdominal pain and diarrhea for years before I decided to go to the doctor," said Amy Dixon. "After struggling to find answers, I finally decided to talk to my doctor and I was diagnosed with IBS-D."

One of the obstacles in IBS-D treatment stems from a gap in patient-physician communication. The "IBS in America" survey found that sixty-five percent of IBS-D patients experience GI symptoms for at least a year before speaking with their doctor, and forty-six percent of patients wait at least three years before seeking a diagnosis.⁵

Dixon partnered with Allergan because of what she called, "the desire to let people know that they don't have to go through life this way." "No one should have to deal with this condition by themselves. There are resources available to help you start the conversation with your doctor; together you can decide if a prescription medication is right for you," Dixon added.

"Allergan is proud to partner with Amy Dixon to raise much needed awareness around IBS-D. By teaming up with Amy and providing education to patients, we hope to empower people living with this chronic condition to have important conversations with their clinicians and seek medical treatment for their IBS-D symptoms," said Aimee Lenar, Vice President, Gastroenterology at Allergan.

As part of a continued effort to educate patients, Allergan has developed a new website featuring "Amy's Story" and a doctor discussion guide.

To learn more about Amy's Story, IBS-D, and a potential treatment option, visit www.IBSDandAmy.com.

About Amy Dixon

Amy Dixon is a world champion paratriathlete and motivational speaker, appearing on television and radio. Amy speaks internationally about her dedication to overcoming adversity, leadership, disease management and patient advocacy.

About VIBERZI

VIBERZI®(eluxadoline) is a twice daily, oral medication used to treat adults with 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- and kappa- opioid receptor agonist and a delta-opioid receptor antagonist.⁶

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.allergan.com/assets/pdf/viberzi_pi?guid=sem_goo_43700009351345466

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 16 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 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 pharmaceuticals, devices and biologic 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, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care.  This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.

Our Company's success is powered by our more than 16,000 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 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 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, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

¹ Ford AC, Moayyedi P, Lacy BE, et al. American College of Gastroenterology monograph on the management of irritable bowel syndrome and chronic idiopathic constipation. Am J Gastroenterol. 2014;109 Suppl 1:S2-26.

² Population estimates V2015. United States Census website. Available at: https://www.census.gov/quickfacts/table/PST045215/00. Accessed: November 07, 2016.

³ Grundmann O, Yoon SL. Irritable bowel syndrome: epidemiology, diagnosis and treatment: an update for health-care practitioners. J Gastroenterol Hepatol. 2010;25(4):691-9.

⁴ Saito YA, Schoenfeld P, Locke GR. The epidemiology of irritable bowel syndrome in North America: a systematic review. Am J Gastroenterol. 2002;97(8):1910-5.

⁵ IBS in America, Consumer Survey, Q19B "Approximately how long did you experience gastrointestinal pain before you went to see a doctor about your symptoms? n=3,254

⁶ Viberzi Prescribing Information – Revised January 2016: http://www.allergan.com/assets/pdf/viberzi_pi?guid=sem_goo_43700009351345466

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Frances DeSena
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SOURCE Allergan plc

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