Eluxadoline receives final approval from NICE for the treatment of IBS with diarrhoea

Allergan has announced that the National Institute of Health and Care Excellence (NICE) has published Final Guidance, with the positive recommendation 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.^2–4

The Final Guidance 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.¹

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, “Until now doctors have had limited options when it comes to treating IBS-D and unfortunately this has been to the detriment of patients, many of whom endure debilitating symptoms on a daily basis. For doctors to now be able to prescribe Truberzi^®, a targeted treatment, this will signify real change for IBS-D sufferers. I am very much looking forward to seeing my patients reap the benefits”.

Nicola Massey, Country Manager, Allergan UK & Ireland, said “Allergan is delighted that NICE has provided final positive guidance for Truberzi^®. We understand the profound impact that IBS-D can have on sufferers and are extremely proud to be offering patients, via the NHS, the first IBS-D treatment with a positive NICE TAG.”

References

1. https://www.nice.org.uk/guidance/ta471 (last accessed 30 August, 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.