CHMP recommends Constella (Almirall) for for the symptomatic treatment of Irritable Bowel Syndrome.

The European Medicines Agency�s Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of the first medicine specifically for the symptomatic treatment of Irritable Bowel Syndrome (IBS) in the European Union (EU). The Agency is recommending that Constella (linaclotide) from Almirall in Europe, be authorised for adults with moderate to severe IBS with constipation (IBS-C), a common subtype of the disease. Linaclotide is a new, synthetic 14-amino-acid peptide, which works by increasing the secretion of fluid in the intestine and accelerating the movement of material through the gut.

The Committee based its recommendation on the results of two main clinical studies showing superiority of linaclotide over placebo in terms of improving symptoms after 12 weeks. These effects were sustained for at least six months. However, it noted that around half of the patients in the main studies did not respond to linaclotide sufficiently, leading to the recommendation that prescribers should assess patients regularly and reconsider treatment if there is no improvement in symptoms after four weeks.