After relatively successful Phase III trials Ironwood Pharmaceuticals’ has applied for final FDA approval of their flagship drug, Linaclotide, which is for the treatment of constipation & pain related Irritable Bowel Syndrome symptoms.
On Aug 9th, Ironwood Pharmaceuticals formally submitted their application to the FDA for Linaclotide to be allowed for prescription by doctors. Linaclotide is a guanylate cyclase type‐C (GC‐C) agonist drug which is aimed at the treatment of those who have Irritable Bowel Syndrome constipation & pain. Included with the application is data regarding the results of Phase III trials. Ironwood Pharmaceuticals is positive that the results of those trials supports Linaclotide’s efficacy & safety. The FDA often takes up to 60 days just to accept the initial application & they will probably not make an official determination on Linaclotide until sometime in 2012.
Linaclotide does look as though it could offer some benefit to those who have constipation or pain as their predominant Irritable Bowel Syndrome symptoms & who have not found relief from diet change or over the counter laxatives.