# Sucampo submits NDA for lubiprostone



## jjohnson (Apr 29, 2004)

Here's a bit of good news for IBS-C sufferers to offset the day's horrible news for those of us with IBS-D (re: cilansetron.) Lubiprostone has been submitted for an indication for chronic constipation and is about to start phase III trials for IBS-C. Since the drug has worked in men and has no safety problems, as far as I know, that would prevent people over 65 from using it, I think it stands a very good chance of obtaining priority (6-month) review, since it would qualify as superior to currently available treatments.http://biz.yahoo.com/prnews/050401/nyf026.html?.v=3


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## SpAsMaN* (May 11, 2002)

http://www.endonurse.com/hotnews/55h169181533012.htmlPhase III Clinical Program Evaluates Lubiprostone for the Treatment of Constipation-Predominant Irritable Bowel Syndrome Posted on: 05/16/2005 BETHESDA, Md. -- 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 idiopathicconstipation 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, MD, clinical associate professor at the 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 aunique mechanism of action. Taken orally, the agent has been shown to worklocally and specifically in the GI tract by activating a specific chloridechannel (CLC2). Chloride channels are proteins that carry chloride on cellslining the small intestine. When activated, these cells increase intestinalfluid secretion. This increased fluid secretion improves stool frequency andconsistency that could result in reduced abdominal discomfort, pain andbloating. "This new phase of the clinical development for lubiprostone marks anothersignificant milestone for Sucampo and Takeda because it follows so closely onthe heels of our NDA submission for chronic constipation in March," saidGeorge Perentesis, MD, vice president of research and development atSucampo. "Results from this new phase of lubiprostone research will enable usto evaluate the feasibility of pursuing an IBS-C indication for this compoundand possibly offering another option for people who live with this condition." For more information about enrollment, call (301) 961-3400. Source: Sucampo Pharmaceuticals, Inc.


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