On August 30, 2012 Ironwood Pharmaceuticals Inc. and Forest Laboratories Inc. gained U.S. regulatory approval of Linaclotide for the treatment of irritable bowel syndrome with constipation (IBS-C). The trade name for Linaclotide is Linzess. The National Institutes of Health estimates that roughly 63 million people are affected by chronic constipation, and about 15.3 million people suffer from irritable bowel syndrome, also known as IBS. With the advent of the Linaclotide approval, excitement is on the horizon for research and development teams, physicians and patients. Linaclotide is a first in class, 14-amino acid peptide guanylate cyclase-C (GC-C) receptor agonist, as well as an intestinal secretagogue.
Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. reported positive findings 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 than 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. Diarrhea was the most common adverse event reported in trial participants treated with Linaclotide, alongside minor complaints of side effects like flatulence and headaches. Linaclotide is an oral capsule and is recommended to be taken on an empty stomach, at least 30 minutes before a meal.
Analysts are hopeful about the future of Linzess. Edward Nash, an analyst with Cowen & Co, was quoted by Bloomberg stating that, “Peak sales for Linaclotide may reach $1.35 billion.” In addition, Gregory Wade, an analyst with Wedbush Securities was quoted by the New York Times voicing his sales projection of Linzess, which echoed a similar upbeat tone. Mr. Wade stated that he expected sales of Linzess (Linaclotide) to exceed $2 billion a year by 2019. These staggering and amazingly profitable numbers are creating a whirlwind of attention for this newly approved visionary drug. The future of Linaclotide looks promising.
LGM Pharma is a supplier of Linaclotide, CAS# 851199-59-2 for research and development purposes.
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