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news.Sucampo Pharmaceuticals said that a new study has demonstrated that the active ingredient in Amitiza, given 8mcg twice a day, may improve symptom relief rates in adults with irritable bowel syndrome with constipation.
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Amitiza (lubiprostone) is marketed in the US for chronic idiopathic constipation, and the new study compared Amitiza with placebo in two groups of patients with irritable bowel syndrome with constipation (IBS-C).
“In this study, patients receiving lubiprostone were nearly twice as likely to achieve an overall response from symptoms of IBS-C compared to those receiving placebo,” said Douglas Drossman, primary investigator, University of North Carolina.
IBS is a condition that affects approximately 58 million Americans and accounts for 25-50 percent of referrals to gastroenterologists. IBS-C symptoms include abdominal pain or discomfort associated with defecation or a change in bowel habits with features of disordered defecation.
Sucampo expects to submit a supplemental New Drug Application for IBS-C to the FDA by July 2007.