Allergan has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Truberzi (eluxadoline) for the treatment of irritable bowel syndrome with diarrhoea (IBS-D).
In two pivotal trials, Truberzi significantly reduced two of the most bothersome symptoms of IBS-D, abdominal pain and diarrhoea, with sustained relief demonstrated over six months. The drug was generally well tolerated with the most common side effects being nausea, constipation, and abdominal pain.
"With this positive decision for Truberzi, Allergan is one step closer to bringing this innovative medication to IBS-D patients across Europe who are in desperate need of new treatment options," said David Nicholson, chief R&D officer, Allergan. "Once approved, the drug will join Constella (linaclotide) as the only licensed prescription medications proven to treat bothersome symptoms of IBS-D and irritable bowel syndrome with constipation (IBS-C) respectively."
Professor Jan Tack, Professor of Internal Medicine at the University of Leuven, Belgium, added: "IBS-D can severely affect patient quality of life and in some cases it can be 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. Truberzi has the potential to become the only licensed treatment for IBS-D in Europe providing a valuable, evidence-based treatment option for patients."
Around one third of IBS patients are estimated to have IBS-D. In a pan-European survey, it is estimated that approximately 3.5 million people across western European countries have IBS-D.