European regulators have issued a green light for Allergan and Aptalis Pharma's Truberzi, giving patients potential access to the first approved treatment for irritable bowel syndrome with diarrhoea (IBS-D).
The approval was based on data from two pivotal Phase III trails in which Truberzi (eluxadoline) showed a significant reduction in two of key symptoms linked with the condition - abdominal pain and diarrhoea - with sustained relief demonstrated over six months.
According to Allergan, its drug was also generally well tolerated with the most common side effects of treatment being nausea, constipation, and abdominal pain.
"IBS with diarrhoea can have a significant impact on patients, and there is a real need for treatment options that help these patients regain control of their lives," said Christian Szita, VP of International Strategic Marketing, Specialty Care at Allergan.
"The European approval of Truberzi as the only licensed treatment for IBS-D is a welcome new treatment option for patients in Europe."
The company said it is expecting to launch the drug next year following negotiations with payer and reimbursement groups. Aptalis Pharma is the current applicant of the marketing authorisation for Truberzi but the MA is in the process of being transferred back to Allergan. This should be finalised within the next two months.
IBS is estimated to affect around 11 percent of people over 15 years of age - around one third of these are thought to have IBS-D.