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Taking Constipation Seriously: Linaclotide Success Raises Hopes For Market Resurgence

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The constipation and irritable bowel syndrome markets have sucked up some prescription drug contenders like quicksand. But the Phase IIII success of Ironwood Pharmaceuticals' linaclotide is renewing hope that an underserved and arguably under-appreciated market could blossom, despite regulatory and commercial challenges that have hindered candidates in the past.

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Irritable bowel syndrome is a promising, but challenging, U.S. market opportunity. On the one hand it offers a large patient population, which is only modestly served by two prescription therapies, but on the other, FDA sets a high safety bar for approving new IBS therapies because the condition is not seen as life-threatening.

IBS-D Lead May Go To Tioga With Salix Required To Run Another Trial

Irritable bowel syndrome is a promising, but challenging, U.S. market opportunity. On the one hand it offers a large patient population, which is only modestly served by two prescription therapies, but on the other, FDA sets a high safety bar for approving new IBS therapies because the condition is not seen as life-threatening.

Ironwood Eyes Large Market For Linaclotide, Will Tread Carefully On Price

Ironwood Pharmaceuticals Inc. is confident about the large market potential for its constipation drug linaclotide, but as the market now is dominated by over-the-counter laxatives, it knows it has to be "smart" when it comes to price in order to win over payers.

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