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Allergan Receives Positive Opinion For Truberzi from CHMP

 

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Allergan plc, a leading global pharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion for TRUBERZI (eluxadoline) in the European Union. TRUBERZI is an oral medication that relieves the main symptoms of irritable bowel syndrome with diarrhoea (IBS-D) in adults. 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.  TRUBERZI 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, TRUBERZI 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. Offering these effective treatment options to physicians and their patients underscores Allergan's commitment to helping address unmet needs in gastrointestinal diseases."

"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," said Prof. Jan Tack, Professor of Internal Medicine at the University of Leuven, Belgium. "TRUBERZI® has the potential to become the only licensed treatment for IBS-D in Europe providing a valuable, evidence-based treatment option for patients."

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