Ironwood Pharmaceuticals is seeking approval from the European Medicines Agency for their Irritable Bowel Syndrome drug Linaclotide.
Almirall is the licensee of Linaclotide for European markets. They along with Linaclotide manufacturer, Ironwood Pharmaceuticals, submitted a Marketing Authorization Application to the European Medicines Agency in a bid to gain access to European markets. Along with the application they submitted the results of their Phase III trials showcasing the benefits they feel Linaclotide provides patients who are dealing with Irritable Bowel Syndrome. If approved the drug would be sold under the brand name of Constella.
Linaclotide is a drug that aids those dealing with constipation related to Irritable Bowel Syndrome. It is an agonist of the guanylate cyclase type‐C receptor which is found in the surface structure of the intestinal system. Studies on Linaclotide in the US suggest that it aids constipation by increase intestinal fluid secretions, reducing visceral hypersensitivity & accelerating transit through the digestive system. Usually it’s well tolerated, but in some cases caused adverse reactions, such as chronic diarrhea, requiring approximately 5% of the trial participants to stop taking it.
Ironwood Pharmaceuticals is still awaiting approval from the United States’ FDA after they submitted a request for final approval following their Linaclotide Phase III trials. The FDA is not expected to make a decision until 2012.
Ironwood’s stock hit a 52-week low on Oct 4th, 2011, although this may have more to do with the current bearish market rather than the state of their business ventures.