European Commission approves Constella(Almirall/Ironwood) for Irritable Bowel Syndrome with Constipation
Almirall, S.A. and Ironwood Pharmaceuticals, Inc. announced that the European Commission has granted marketing authorization to Constella (linaclotide 290mcg) for the symptomatic treatment of moderate to severe Irritable Bowel Syndrome with Constipation (IBS-C)in adults.
Constella is an oral, once-daily medication. Linaclotide, the active ingredient in Constella, is a guanylate cyclase-C agonist (GCCA) with visceral analgesic and secretory activities, as stated in the product label for European use. In non-clinical studies, linaclotide has been shown to reduce visceral pain by decreasing pain-fiber activity and to accelerate gastrointestinal transit by increasing intestinal fluid secretion. Linaclotide acts locally in the intestine with minimal systemic exposure.
Almirall expects to begin launching Constella in Europe in the first half of 2013.