Allergan's Truberzi® (eluxadoline) Receives Positive Recommendation from NICE for the Treatment of Irritable Bowel Syndrome with Diarrhoea (IBS-D) in Adults

Recommendation paves the way for the first medicine specifically licensed for IBS-D to be routinely NHS funded by the Autumn

MARLOW, England, July 27, 2017 /PRNewswire/ -- Allergan announced today that the National Institute of Health and Care Excellence (NICE) has published a Final Appraisal Determination, recommending that Truberzi (eluxadoline) be made available on the National Health Service for adults living with Irritable Bowel Syndrome with Diarrhoea (IBS-D)¹.

Truberzi® is a first-in-class, twice daily, oral medication offering sustained relief from multiple symptoms of IBS-D, such as pain, diarrhoea, urgency and bloating^2,3. In two pivotal Phase III trials, Truberzi® demonstrated a significant reduction in the two most bothersome symptoms of IBS-D, abdominal pain and diarrhoea, with fast and sustained relief for over six months. Treatment effect can be seen within 1 week, reaches maximal effect after 6 weeks and is sustained over 6 months.^2,3,4

The Final Appraisal Determination (FAD) recommends Truberzi^® for patients whose IBS-D has not responded to other treatments routinely used for IBS-D (or who cannot tolerate or are contraindicated to such treatments) and that treatment is initiated in hospital. NICE expects to publish the final guidance at the end of August, assuming there is no appeal against the FAD.¹

Today's news has been widely welcomed by the gastroenterology community: Dr Adam Farmer, Consultant Gastroenterologist at University Hospitals of North Midlands and Scientific Advisor at the IBS Network, the UK's national charity for IBS said, "IBS-D can severely affect patient quality of life and, in some cases, is very debilitating. In the absence of effective medications, doctors and patients have had few options available beyond over-the-counter medicines, as well as diet and lifestyle modifications."

Peter Paine, Neurogastroenterologist at Salford Royal Foundation trust added, "This positive recommendation for Truberzi®, means that those treating IBS-D will now have access to a therapy specifically targeting their patients' symptoms, when other less tailored approaches have failed."

Nicola Massey, Country Manager, Allergan UK & Ireland, said, "Allergan is pleased that NICE proposes to recommend that patients who are struggling to manage their IBS-D are offered access to Truberzi®. It is the first medicine specifically licensed for treating IBS-D to have been made available through the NHS, and the FAD should open the way to routine funding for patients across England and Wales. We look forward to the FAD being translated into final guidance and then being implemented across the health service."

Note to Editors:

About Truberzi®

Truberzi® (eluxadoline) is a twice daily, oral medication indicated for use in adults suffering from Irritable Bowel Syndrome with diarrhoea (IBS-D). Truberzi® has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.²

Truberzi is currently available in the UK in 75mg and 100mg, twice daily film-coated tablets³. Truberzi is also available in the U.S. as Viberzi.

About Irritable Bowel Syndrome with Diarrhoea

Irritable Bowel Syndrome with Diarrhoea (IBS-D) is a functional bowel disorder characterised by chronic abdominal pain, frequent diarrhoea, bloating and urgency.^2,3 IBS is estimated to affect over 11% of people over 15 years of age^5,6 and approximately one-third of these are thought to suffer with IBS-D.7 Although the exact cause of IBS is not known⁸, symptoms are thought to result from a disturbance in the way the gastrointestinal tract and nervous system interact.⁹

IBS-D can be debilitating and there are limited therapeutic options for managing the chronic symptoms.¹¹ 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.^12-15

About Allergan plc

Allergan plc 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.

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.

For more information, visit Allergan's website at www.Allergan.co.uk

References

1. https://www.nice.org.uk/guidance (last accessed 26 July, 2017)
2. Lembo AJ, et al. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med 2016; 374:242-253
3. TRUBERZI® (eluxadoline) Summary of Product Characteristics. Last Accessed July 2017
4. 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 September 2016.
5. Canavan C et al.  The epidemiology of IBS Clin Epidemiol 2014
6. Lovel RM et al. Global prevalence of and risk facts of IBS. Clin Gasterenterol Hepatol
7. Spiller R et al. Guidelines on the Irritable Bowel Syndrome mechanisms and Gut 2007;56: 1770-1798 (641.70 KB) mechanisms and Gut 2007;56: 1770-1798 (641.70 KB) mechanisms and Gut 2007;56: 1770-1798 (641.70 KB) mechanisms and Gut 2007;56: 1770-1798 (641.70 KB)
8. Sainsbury A and Ford A. Treatment of irritable bowel syndrome: beyond fiber and antispasmodic agents. Therapeutic advances in gastroenterology. 2011;4(2):115-27.
9. Saha L. Irritable bowel syndrome: Pathogenesis, diagnosis, treatment, and evidence-based medicine. World J Gastroenterol. 2014;20(22):6759-73.
10. Drossman DA, Morris CB, Schneck S, et al. International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit.
11. Farndale R, Roberts L. Long-term impact of irritable bowel syndrome: a qualitative study. Primary Health Care Research & Development. 2011;12;52-67
12. Allergan Data on File INT/0207/2016d Date of Preparation 27th April 2016
13. Camilleri M, et al. Economic burden of irritable bowel syndrome proposed strategies to control expenditures. Pharmacoeconomics 2000;(17)4:331–8.
14. Cash B, et al. Total Costs of IBS: Employer and Managed Care Perspective. Am J Manag Care 2005 Apr;11(1 Suppl):S7–16.
15. Volmer T, et al. Cost of illness studies may largely underestimate the cost of diseases with unmet medical need such as irritable bowel syndrome (IBS). Value Health 1999;2(5):399–399.

CONTACTS: 

Media:
Laura Aplin
Tel: 07891 426 908
aplin_laura@allergan.com

Janet Kettels
Tel: 07738 506 475
Kettels_janet@allergan.com

Logo - http://mma.prnewswire.com/media/222796/allergan_plc_logo.jpg