Bethesda, MD (January 31, 2006)-- Sucampo Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has approved the new drug application for AMITIZA™ (lubiprostone) capsules, an oral treatment of chronic idiopathic constipation in adults. AMITIZA™ is the first selective chloride channel activator approved for therapeutic use and has been shown to offer effective relief of chronic idiopathic constipation in adults. This condition affects women more often than men and also affects older patients after the age of 65 more frequently.
The approval is primarily based on data from two pivotal, double-blind, placebo-controlled studies, which showed that approximately 60 percent of patients who used AMITIZA™ experienced a spontaneous bowel movement within the first 24 hours. Additionally, AMITIZA™ was shown to decrease abdominal bloating, abdominal discomfort and constipation severity when administered over the 6-12 month treatment period.
“AMITIZA™ provides an onset of action within 24 hours of administration and can provide relief of symptoms of constipation such as stool consistency and straining,” said John F. Johanson, M.D., clinical associate professor, University of Illinois College of Medicine, and lead investigator on lubiprostone studies since the beginning of Phase 2 of development.
AMITIZA™ works by increasing fluid secretion and motility in the intestine, and thereby increasing the passage of the stool and alleviating symptoms associated with chronic idiopathic constipation.
AMITIZA™ is contraindicated in patients with a known hypersensitivity to the drug or its components, and in patients with a history of mechanical gastrointestinal obstruction. The safety of AMITIZA™ during pregnancy has not been evaluated. Women planning to use AMITIZA™ should confirm that they are not pregnant prior to start of medication. The most common side effects associated with AMITIZA™ treatment during clinical trials were nausea, diarrhea, and headache. Taking AMITIZA™ with a meal or food may reduce the symptoms of nausea.
“AMITIZA™ delivers targeted, predictable relief to help people with chronic constipation,” said Sachiko Kuno, Ph.D., Co-Founder, President and Chief Executive Officer of Sucampo. “As a science-driven pharmaceutical company, Sucampo is pleased to be able to provide a new drug based on a novel mechanism of action that has the potential to help millions.”
Constipation is one of the most common digestive complaints, affecting over 33 million adults in the United States . It is the cause of 2.5 million visits to physicians and 92,000 hospitalizations annually.
”The FDA approval of AMITIZA™ for adult women and men of all ages with chronic constipation should provide improvement of symptoms to a great number of people who now suffer from the condition,” said Anthony J. Lembo, M.D., assistant professor of medicine, Beth Israel Deaconess Medical Center and Harvard Medical School.
AMITIZA™ will be jointly marketed by Sucampo Pharmaceuticals, Inc., and Takeda Pharmaceuticals America, Inc., a wholly owned subsidiary of Takeda Pharmaceuticals North America, Inc., and will be available in the United States in spring of 2006.
About AMITIZA™ (lubiprostone)
AMITIZA™ is the first and only chloride channel activator approved for the treatment of chronic idiopathic constipation in adults. It increases fluid secretion into the intestinal tract by locally activating specific ClC-2 chloride channels (proteins that transport chloride) on cells lining the small intestine. For full prescribing information, visit www.AMITIZA.com.
About Chronic Idiopathic Constipation
Chronic idiopathic constipation is defined by the infrequent or difficult passage of stool for a period of at least three months. It may be caused by abnormal colonic motility that can delay the movement of intestinal contents and impede evacuation. The signs and symptoms associated with chronic idiopathic constipation include abdominal pain or discomfort, bloating, straining, and hard or lumpy stools.
Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a science-driven pharmaceutical company, based in Bethesda , Md. , focusing on gastrointestinal and specialty diseases. Sucampo has concentrated on developing and commercializing drugs from its proprietary prostone technology platform, which was created by Ryuji Ueno, M.D., Ph.D., Ph.D., Co-Founder, Executive Chair and Chief Scientific Officer of the company. Prostones are a new class of functional fatty acid with a variety of physiological and pharmacological activities. The first commercial prostone product, RESCULA®, was launched in 1994 in Japan , and later approved in more than 40 other countries for the treatment of glaucoma. AMITIZA™ is Dr. Ueno’s second prostone product to be marketed in the United States , and the first selective chloride channel activator for therapeutic use. To learn more about the company and its products, visit www.sucampo.com .
In October 2004, Sucampo entered into an agreement with Takeda Pharmaceutical Company Limited ( Osaka , Japan ) to jointly market AMITIZA™ in the United States and Canada. Takeda Pharmaceuticals America, Inc. and Takeda Pharmaceuticals North America, Inc. are US subsidiary companies of Takeda. To learn more about Takeda, visit www.takeda.co.jp and www.tpna.com
Sucampo Pharmaceuticals, Inc
Name: Brad Fackler
Dept.: Media Relations
Takeda Pharmaceutical Company Limited
Name: Seizo Masuda
Dept.: Corporate Communications Dept.