AMITIZA™ (lubiprostone) launches in the United States
Novel mechanism of action provides effective and predictable relief for adults living with chronic idiopathic constipationBethesda, Md., and Lincolnshire, Il.– Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc., announced today that AMITIZA (lubiprostone), 24-mcg soft-gel capsules, approved by the U.S. Food and Drug Administration (FDA) in January 2006, is now available by prescription in pharmacies across the United States for the treatment of chronic idiopathic constipation in adults. AMITIZA (pronounced ahm-e-TEASE-a) is the first selective chloride channel activator approved for therapeutic use in chronic idiopathic constipation, a condition that affects both men and women and affects patients over the age of 65 more frequently.
"AMITIZA is an important new option for people living with chronic idiopathic constipation who may be unsatisfied with traditional treatment options, including lifestyle and dietary changes, laxatives and stool softeners," said Sachiko Kuno, Ph.D., co-founder, president and chief executive officer of Sucampo. "As a science-driven pharmaceutical company, Sucampo is pleased to work with Takeda Pharmaceuticals North America to make this innovative new therapeutic option available to physicians and patients in the United States."
AMITIZA works by increasing fluid secretion locally in the small intestine by activating the ClC-2 chloride channel, and thereby increasing the passage of the stool and improving symptoms associated with chronic idiopathic constipation. In clinical trials, 60 percent of patients who used AMITIZA experienced a spontaneous bowel movement within the first 24 hours.
AMITIZA improved signs and symptoms related to chronic constipation, including abdominal bloating, discomfort, stool consistency and straining. Additionally, these symptomatic improvements lasted over the six to 12 month treatment period.
"The availability of AMITIZATM is exciting news for the millions of Americans who suffer from chronic idiopathic constipation and deal with its daily consequences," said John Johanson, M.D., clinical associate professor, University of Illinois College of Medicine. "Unlike many treatments that may fail to control symptoms adequately or lose effectiveness with time, AMITIZA provides fast and predictable relief of chronic idiopathic constipation."
AMITIZA is developed by Sucampo Pharmaceuticals, Inc., and will be jointly marketed in the United States by Sucampo Pharmaceuticals, Inc., and Takeda Pharmaceuticals North America, Inc. The AMITIZA sales force in the United States will comprise representatives from both companies.
"Takeda looks forward to working with Sucampo to successfully launch AMITIZA and help make it a trusted and valuable therapy for the treatment of chronic idiopathic constipation," said Art Rice, general manager, Gastroenterology. "AMITIZA has been shown to deliver targeted and predictable relief to people with chronic idiopathic constipation, and we believe that through its novel mechanism of action, this drug may help fill an important therapeutic gap for many patients."
About Chronic Idiopathic Constipation
Constipation is one of the most common digestive complaints, affecting more than 30 million adults in the United States. It is the cause of 2.5 million visits to physicians and 92,000 hospitalizations annually. Chronic idiopathic constipation is defined by the infrequent or difficult passage of the 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.
About AMITIZA (lubiprostone)
AMITIZA is indicated for the treatment of chronic idiopathic constipation in the adult population.
AMITIZA should not be used in patients with a known hypersensitivity to any components of the formulation and in patients with a history of mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be evaluated prior to initiating AMITIZA treatment.
The safety of AMITIZA in pregnancy has not been evaluated in humans. In guinea pigs, lubiprostone has been shown to have the potential to cause fetal loss. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.
AMITIZA should not be administered to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. If the diarrhea becomes severe, patients should consult their health professional.
In clinical trials, the most common adverse event was nausea (31%). Other adverse events (≥5% of patients) included diarrhea (13%), headache (13%), abdominal distention (7%), abdominal pain (7%), flatulence (6%), sinusitis (5%) and vomiting (5%).
For full prescribing information, visit http://www.amitiza.com.
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., Co-Founder, Executive Chair, Chief Operating Officer 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 Japan, and later in more than 40 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 http://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 U.S. subsidiary companies of Takeda.
Takeda Pharmaceuticals North America, Inc.
Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes, insomnia, cholesterol-lowering and gastroenterology treatments, and has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit www.tpna.com.
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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