Sucampo Pharmaceuticals submits supplemental new drug application for Lubiprostone to treat IBS-C

Sucampo Pharmaceuticals, Inc., (Sucampo Pharmaceuticals) today announced that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration to seek market approval of a lower strength of lubiprostone (8 mcg) to treat irritable bowel syndrome with constipation (IBS-C). Lubiprostone, developed by Sucampo Pharmaceuticals, is currently approved for the treatment of Chronic Idiopathic Constipation in adults as AMITIZA (24 mcg) and is marketed by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America, Inc., (Takeda) in the U.S. for that indication.

IBS-C has a significant impact on millions of Americans living with the condition, said Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals founder, chairman and chief executive officer. We are excited that the results of our clinical studies have led to the successful filing of a supplemental New Drug Application for a lower strength of lubiprostone [8 mcg, twice daily] for IBS-C. If approved, lubiprostone may offer a new treatment option for people living with this condition.

Approximately 58 million Americans have irritable bowel syndrome, with IBS-C accounting for approximately one-third of these cases. IBS-C symptoms include abdominal pain and discomfort associated with defecation or a change in bowel habits with features of disordered defecation.

The supplemental application is based on a clinical study program that included two Phase III, multi-center, 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. In the two Phase III studies, patients received lubiprostone 8 mcg taken twice daily (783 adults) or placebo (388 adults) over a 12-week period. In both trials, patients receiving lubiprostone 8 mcg twice daily were nearly twice as likely to achieve an overall response that was statistica

Contact: Stephanie Donlan

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