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  • equityvaluation equityvaluation May 11, 2010 9:22 PM Flag

    FRX's IBS drug slated for FDA NDA in 2011

    Press Release Source: Ironwood Pharmaceuticals, Inc. On Tuesday May 11, 2010, 7:00 pm EDT
    CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD - News) today provided an update on its business activities for the first quarter of 2010.

    First Quarter 2010 Highlights


    •In March, the final patients were enrolled into each of the two confirmatory Phase 3 clinical trials being carried out by Ironwood and its U.S. partner, Forest Laboratories, Inc., to assess the efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation (IBS-C). Ironwood and Forest anticipate that the top-line data from the two trials will be reported separately in the fourth quarter of 2010. Ironwood and Forest are targeting a New Drug Application submission for both IBS-C and chronic constipation (CC) in the middle of 2011.
    •At the end of March, the U.S. Food and Drug Administration (FDA) issued draft guidance on the design of clinical trials for IBS-C. The draft guidance calls for co-primary efficacy endpoints assessing abdominal pain (≥ 30 percent average weekly reduction versus baseline) and stool frequency (increase of one or more complete spontaneous bowel movements per week versus baseline). The co-primary endpoints in the above-mentioned Phase 3 IBS-C clinical trials are closely aligned with the draft guidance.
    •The European Medicines Agency (EMA) has indicated that Ironwood’s European partner, Almirall, S.A., can utilize the U.S. IBS-C Phase 3 clinical trials as a basis for a Market Authorisation Application. For that reason, no additional E.U. Phase 3 clinical trials are contemplated. The primary endpoint will be different in Europe, but both the EMA and the FDA have agreed to allow separate and independent statistical analysis plans of the primary data sets for the two territories. For the E.U., the co-primary efficacy endpoints will evaluate abdominal pain/abdominal discomfort and IBS degree of relief.

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