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Home Industry News Allergan’s IBS-D therapy Truberzi recommended by CHMP for EU approval

Allergan’s IBS-D therapy Truberzi recommended by CHMP for EU approval

26th July 2016

Allergan has announced that its new irritable bowel syndrome therapy Truberzi has been recommended for European regulatory approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Truberzi as a means of relieving the main symptoms of irritable bowel syndrome with diarrhoea (IBS-D) in adults.

In two pivotal trials, the oral medication was shown to significantly reduced abdominal pain and diarrhoea, with sustained relief demonstrated over six months, as well as being generally well tolerated.

It is estimated that around 11 percent of people worldwide have some form of IBS, with around one-third of them having IBS-D.

David Nicholson, chief research and development officer at Allergan, said: "Once approved, Truberzi will join Constella as the only licensed prescription medications proven to treat bothersome symptoms of IBS-D and irritable bowel syndrome with constipation respectively."

The company also applied for US regulatory approval of its new Oculeve Intranasal Tear Neurostimulator device earlier this month.ADNFCR-8000103-ID-801822462-ADNFCR

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