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FDA accepts Sucampo’s lubiprostone sNDA for review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA has accepted Sucampo's supplemental NDA for lubiprostone (8 mcg) for the treatment of irritable bowel syndrome with constipation. A standard 10-month review would set the clock for an April 29, 2008, user fee date. The sNDA is supported by two Phase III double-blinded, randomized, placebo-controlled trials involving 1,171 adults, followed by one long-term open-label safety and efficacy extension trial involving 522 adults diagnosed with IBS-C. Marketed by Sucampo and Takeda as Amitiza in a higher dosage form (24 mcg), lubiprostone was approved in January 2006 for the treatment of chronic idiopathic constipation in adults...

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