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A treatment for irritable bowel syndrome developed by Cambridge-based Ironwood Pharmaceuticals Inc. (Nasdaq: IRWD) and partner Forest Laboratories Inc. (NYSE: FRX), of New York, has achieved positive results in a second Phase 3 clinical trial, meeting both primary and secondary endpoints.
Linaclotide, the treatment of irritable bowel syndrome with constipation (IBS-C), was found to have improved results in patients taking the drug candidate, over those taking placebo, in measures of abdominal pain, abdominal discomfort, bloating and bowel symptoms.
The trial followed positive results in the first of the two Phase 3 trials, which Ironwood officials noted would be used to support plans for regulatory approval of linaclotide in Europe. The company is working with its European partner Almirall S.A. to reach E.U. approval of linaclotide.
According to a news release from Ironwood, the companies plan to submit a new drug application (NDA) to the U.S. Food and Drug Administration in the third quarter of 2011 for linaclotide, in treating irritable bowel syndrome with constipation, as well as chronic constipation.
Ironwood Pharmaceuticals brought in $188 million in its February initial public offering, before underwriters exercised an over-allotment option, bringing the company’s net proceeds to $203 million.
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