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HeatherAdministrator

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3-month FDA delay for potential IBS drug linaclotide
04/23/12 01:45 PM

Ironwood faces 3-month FDA delay for potential IBS drug linaclotide

Boston Business Journal by Julie M. Donnelly, Reporter

Date: Monday, April 23, 2012, 2:03pm EDT


Ironwood Pharmaceuticals and its partner Forest Laboratories Inc. have announced the U.S. Food and Drug Administration will delay its approval decision for the companies potential drug for irritable bowel syndrome (IBS), called linaclotide.

The delay is due to the agencys request for an additional analysis of existing clinical data, the companies said. The FDA has not requested a new clinical trial.

The drug candidate was submitted to the FDA in August 2011 and a decision was expected in June. In February the company had received an encouraging sign that the approval process was on schedule, sending shares up 7 percent.

FDA action is now expected by September. Cambridge, Mass-based Ironwood and New York-based Forest continue to plan for a 2012 launch.

The efficacy and safety of linaclotide was studied in a clinical trial program of more than 2,800 patients for the treatment of irritable bowel syndrome with constipation and chronic constipation.

Ironwood and Forest plan to co-promote linaclotide in the U.S. Ironwood has out-licensed linaclotide to Almirall for European development and commercialization, and to Astellas Pharma Inc. for development and commercialization in Japan, Indonesia, Korea, the Philippines, Taiwan, and Thailand.

http://www.bizjournals.com/boston/news/2012/04/23/ironwood-faces-three-month-fda-delay.html

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Heather is the Administrator of the IBS Message Boards. Shes the author of Eating for IBS and The First Year: IBS, and the CEO of Heather's Tummy Care. Join her IBS Newsletter. Meet Heather on Facebook!

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