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news.Sucampo Pharma Ltd, a wholly owned subsidiary of Sucampo Pharmaceuticals, has filed a marketing application for Amitiza (lubiprostone) 24mcg as a treatment for chronic idiopathic constipation (CIC) with the Japanese Pharmaceuticals and Medical Devices Agency.
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To support the marketing application, the company has also provided the positive results of a Phase 3 efficacy trial which met primary endpoint and showed safety profile consistent with previously reported Lubiprostone clinical data.
The submission will be amended in early 2011 with the complete results of the Phase 3 long-term, open-label, multi-center, confirmatory, safety trial in 209 Japanese CIC patients. Top-line interim results from this trial were disclosed in August 2010 and top-line final results from this safety trial continue to be expected during the fourth quarter of 2010.
Sucampo chairman and CEO Ryuji Ueno said that they have submitted the Japanese regulatory application for Amitiza and they will work diligently to achieve licensure in order to bring this potentially important new therapeutic tool to Japanese patients.