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Phase III clinical program evaluates lubiprostone

BETHESDA, MD May 16, 2005 Takeda Pharmaceuticals North America (TPNA) and Sucampo Pharmaceuticals announced the initiation of a phase III clinical development program for lubiprostone in patients with constipation-predominant irritable bowel syndrome (IBS-C). Enrollment for these trials begins this month. Lubiprostone is an investigational compound currently being evaluated by the FDA for the treatment of chronic idiopathic constipation and associated pain and bloating in adults.

The IBS-C clinical development program will include two phase III trials. Each trial will examine more than 500 patients for 12 weeks to evaluate the safety and efficacy of lubiprostone.

"Irritable bowel syndrome is a condition that can impact a person's quality of life, but is currently addressed by few available therapies," said John Johanson, M.D., clinical associate professor, University of Illinois College of Medicine, and principal investigator. "Based on results from our phase II study, we believe lubiprostone may have the potential to treat IBS-C, and thus offer a new option for people living with irritable bowel syndrome."

The program includes two double-blind, randomized phase III clinical trials with a treatment period of 12 weeks, taking place at up to 130 sites around the United States. A previous phase II study in IBS-C patients evaluated the effectiveness across a range of doses. Additionally, studies of lubiprostone in chronic constipation have achieved clinical endpoints of relief of constipation and associated pain and bloating and demonstrated tolerability, regardless of gender.

Lubiprostone is a chloride channel activator, a novel compound with a unique mechanism of action. Taken orally, the agent has been shown to work locally and specifically in the GI tract by activating a specific chloride channel (CLC2). Chloride channels are proteins that carry chloride on cells lining the small intestine. When activated, these cells increase in
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