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12:00 AM
 | 
Nov 09, 2009
 |  BioCentury  |  Product Development

Waiting to Fill a Void

Despite good data from two Phase III trials of linaclotide for chronic constipation and the market's need for new treatments, Forest Laboratories Inc. will wait to submit an NDA. Forest says it still needs long-term safety data, which are expected in 2H10, along with results from a Phase III trial to treat irritable bowel syndrome with constipation.

Forest and partner Ironwood Pharmaceuticals Inc. last week announced that once-daily linaclotide met the primary endpoint of a significantly higher complete spontaneous bowel movement (CSBM) overall responder rate vs. placebo at 12 weeks in two Phase III trials. Responders were defined as having three or more CSBMs per week and an increase of at least one CSBM per week over baseline for at least 9 of the 12 weeks.

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