Ironwood, Forest Seek FDA Approval
Cambridge, MA-based Ironwood Pharmaceuticals (NASDAQ: IRWD) and New York-based Forest Laboratories (NYSE: FRX) announced today that they have submitted an application to the FDA for approval of their drug linaclotide, a treatment for irritable bowel syndrome with constipation and chronic constipation.The application includes safety and efficacy data from two long-term safety studies and four placebo-controlled clinical trials. Those four trials involved more than 2,800 patients and showed that linaclotide, Ironwood’s lead drug candidate, provided a statistically significant improvement in abdominal and bowel symptoms when compared against a placebo.
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