VIBERZItm Now Approved in Canada for patients with irritable bowel syndrome with diarrhea (IBS-D)

? First in class treatment offers patients significant relief from multiple symptoms of IBS-D, including abdominal pain, diarrhea, urgency and bloatingⁱ ?

MARKHAM, ON, May 16, 2017 /CNW/ - Allergan Inc. is pleased to announce the Health Canada approval of VIBERZItm (eluxadoline) for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. IBS-D patients suffer from frequent and urgent episodes of diarrhea, abdominal pain, bloating and cramping,ⁱⁱ making it difficult for patients to manage work, family, and social life.ⁱⁱⁱ Despite the significant impact on quality of life, patients often wait years before seeking medical help,^iv relying on multiple prescription and over the counter medications with little success.^v

"There is a real need for a new treatment for IBS-D. Many patients remain dissatisfied with the currently available treatment options and continue to experience multiple distressing symptoms associated with their condition, which negatively impacts their quality of life," said Dr. Louis Liu, gastroenterologist in Toronto, ON. "The availability of VIBERZItm for our patients ?  which has shown to improve diarrhea and abdominal pain by targeting receptors in the gut ? can potentially be a promising new treatment agent to change the way we manage patients living with IBS-D."

In two pivotal Phase III trials published in the New England Journal of Medicine, VIBERZItm demonstrated a significant reduction in abdominal pain and diarrhea in as early as one to four weeks with sustained relief throughout the entire long-term study.^vi,vii

"IBS-D can have an overwhelming impact on the lives of individuals living with the condition, affecting their ability to work and play," said Gail Attara, president and chief executive officer, Gastrointestinal Society. "We're pleased to see the approval of VIBERZItm as a new option to help those who are living with IBS-D manage the multiple symptoms associated with their condition, and ultimately help them regain control of their lives and participate in the activities that matter most to them."

VIBERZItm is also available for use in the United States and is approved in Europe as TRUBERZI^®.

"The approval of VIBERZItm for the treatment of irritable bowel syndrome with diarrhea fills an important unmet need in providing Canadians living with this condition with a new option to better control their symptoms," said Edward Gudaitis, Vice President and Country Manager at Allergan Canada. "This first-in-class treatment demonstrates Allergan's ongoing commitment to improving the lives of Canadians through innovative medicines in gastrointestinal care."

About VIBERZItm
VIBERZItm is a new class of medication acting on local receptors in the gastrointestinal tract. It improves diarrhea and abdominal pain by interacting with mu, and delta opioid receptors located in the intestine to slow GI motility and reduce visceral pain. Activation of the mu-receptor reduces diarrhea while antagonism of the delta-receptor enhances the analgesic activity and reduces the risk of constipation.^viii

Health Canada's approval of VIBERZItm was based on two Phase III double-blind randomized clinical trials, conducted in the United States, Canada and the United Kingdom, evaluating 2,425 adults over a 26 and 52-week period who have IBS-D.^ix The primary endpoint was the proportion of patients who had a composite response of decrease in abdominal pain and improvement in stool consistency on the same day for at least 50 per cent of the days from weeks one through 12 and from weeks one through 26.^x The most common adverse reactions (incidence less than five per cent and greater than placebo) reported in the clinical trials were constipation, nausea and abdominal pain.^xi

About Irritable Bowel Syndrome with Diarrhea
Irritable bowel syndrome is a chronic, often debilitating, functional gastrointestinal disorder that affects approximately four to six million Canadians.^xii It is estimated that one third of patients with IBS have IBS-D.^xiii Although the exact cause of IBS-D is not known,^xiv symptoms are thought to result from a disturbance in the way the gastrointestinal tract and nervous system interact.^xv

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.

About Allergan in Canada
For more information, visit Allergan Canada's website at www.Allergan.ca.

Forward-Looking Statement
Statements contained in this press release referring 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 (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.

References

ⁱ American Gastroenterological Association survey. (2015). IBS in America Summary Survey Findings. Available at: http://ibsinamerica.gastro.org/files/IBS_in_America_Survey_Report_2015-12-16.pdf. Last accessed March 14, 2017.
ⁱⁱ IBS Overview. GI Society. Available at: http://www.badgut.org/information-centre/a-z-digestive-topics/ibs/. Last accessed April 7, 2017.
ⁱⁱⁱ The Hidden Costs: The Economic Impact of IBS. GI Society. Available at: http://www.badgut.org/information-centre/a-z-digestive-topics/hidden-costs-of-ibs. Last accessed March 14, 2017.
^iv IBS Awareness Month. GI Society. Available at: http://www.badgut.org/information-centre/a-z-digestive-topics/ibs-awareness/. Last accessed April 7, 2017.
^v GI Society. 2016 Survey Results; Irritable Bowel Syndrome. Available at: http://www.badgut.org/wp-content/uploads/IBS-Survey-Results-2016.pdf. Last accessed April 11, 2017.
^vi Lembo AJ, et al. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med 2016; 374:242-253.
^vii VIBERZI^TM Product Monograph, January 17, 2017.  
^viii VIBERZI^TM Product Monograph, January 17, 2017.
^ix Lembo AJ, et al. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med 2016; 374:242-253.
^x Lembo AJ, et al. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med 2016; 374:242-253.
^xi Lembo AJ, et al. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med 2016; 374:242-253.
^xii The Hidden Costs: The Economic Impact of IBS. GI Society. Available at: http://www.badgut.org/information-centre/a-z-digestive-topics/hidden-costs-of-ibs. Last accessed March 17, 2017.
^xiii World Gastroenterology Organization Guidelines. Irritable Bowel Syndrome: A Global Perspective. Available at: http://www.worldgastroenterology.org/guidelines/global-guidelines/irritable-bowel-syndrome-ibs/irritable-bowel-syndrome-ibs-english. Last accessed March 14, 2017.
^xiv Sainsbury A and Ford A. Treatment of irritable bowel syndrome: beyond fibre and antispasmodic agents. Therapeutic advances in gastroenterology. 2011;4(2):115-27.
^xv Saha L. Irritable bowel syndrome: Pathogenesis, diagnosis, treatment, and evidence-based medicine. World J Gastroenterol. 2014;20(22):6759-73.

SOURCE Allergan