Linaclotide, CAS Number 851199-59-2, is an exciting new drug, aimed at helping patients with Irritable Bowel Syndorme and Constipation (IBS-C). As patients suffering from both IBS and constipation also experience abdominal pain, linaclotide is touted to relieve both constipation and abdominal pain. Linaclotide is a first in class, 14-amino acid peptide guanylate cyclase-C (GC-C) receptor agonist, as well as an intestinal secretagogue. LGM Pharma is a provider of Linaclotide for research and development purposes.
On October 24, 2011 the FDA accepted for review the New Drug Application (NDA) for linaclotide to treat irritable bowel syndrome with constipation (IBS-C), as well as chronic constipation (CC). The review is expected to take ten months, and the target date for potential approval is aimed for June 2012. Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. have reported positive results from their Stage 3 clinical trials. The most recent data from a Phase 3 program included four double-blind placebo-controlled trials and two open-label long term safety studies. With more then 2,800 patients receiving either a once daily dose of linaclotide or a placebo, significant improvements were noted in the patients who received linaclotide. These patients reported marked improvement with abdominal pain, abdominal discomfort, bloating, and bowel symptoms.
With diarrhea being the most common adverse event reported in linaclotide-treated patients, other unwanted effects reported include flatulence and headaches. Linaclotide is an oral capsule and has been administered once daily in trials. Usually taken before the first meal of the day, doses ranged in trials from 75 to 3000 mcg daily. The duration of therapy ranged from a single dose to 26 weeks.
Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.