AMITIZA 8 mcg dose is the only widely available FDA-approved prescription medication for Irritable Bowel Syndrome with Constipation
Bethesda, Md., and Deerfield, Ill., May 27, 2008 – Sucampo Pharmaceuticals, Inc. (Nasdaq: SCMP) and Takeda Pharmaceuticals North America, Inc. today announced that AMITIZA® (lubiprostone) 8 mcg capsules are now available by prescription in pharmacies across the U.S. for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in women 18 years and older. AMITIZA 24 mcg capsules have been available by prescription to treat Chronic Idiopathic Constipation in adults since 2006.
AMITIZA is the only widely available FDA-approved prescription treatment option that can provide overall symptom relief for the millions of adult women in the U.S. with IBS-C.
AMITIZA has a mechanism of action that works locally in the intestine to increase fluid secretion, resulting in increased passage of stool and alleviating symptoms associated with Chronic Idiopathic Constipation. Although it is not well understood how AMITIZA works to reduce symptoms in patients with IBS-C, ex vivo animal studies suggest that AMITIZA stimulates recovery of mucosal barrier function by restoring tight junction protein complexes.
"The effects of IBS-C can be debilitating and far-reaching—affecting many aspects of a person’s life," said Charles Baum, M.D., gastroenterologist, executive medical director, Gastroenterology and Internal Medicine, at Takeda Pharmaceuticals North America, Inc. "The availability of AMITIZA makes it possible for appropriate patients to receive a widely available prescription medication that can be an important tool to help treat this condition."
"I am very pleased with the quick commercial launch of AMITIZA 8 mcg for this particular indication as it could provide a treatment option to many adult women suffering from IBS-C," said Ryuji Ueno, M.D., Ph.D., Ph.D., founder, chairman and chief executive officer, Sucampo Pharmaceuticals.
AMITIZA was developed by Sucampo Pharmaceuticals and is co-marketed in the U.S. by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America, Inc.
About Irritable Bowel Syndrome with Constipation (IBS-C)
IBS is a disorder characterized by symptoms including abdominal discomfort or pain, bloating and changes of bowel habits such as constipation and/or diarrhea. There are three main types of IBS: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D) and IBS with mixed constipation and diarrhea (IBS-M). In IBS-C, symptoms are present for at least 12 weeks (not necessarily consecutive) over a 12-month period. Although people with IBS-C report many of the symptoms associated with constipation, the presence of abdominal discomfort or pain is what differentiates IBS-C from chronic constipation. IBS is approximately two to two-and-a-half times more prevalent in women than men.
About AMITIZA® (lubiprostone) for Chronic Idiopathic Constipation and IBS-C Indication
AMITIZA® (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg) in women ≥ 18 years old.
Important Safety Information
AMITIZA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating physician to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.
The safety of AMITIZA in pregnancy has not been evaluated in humans. 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.
Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea. Patients who experience severe nausea should inform their physician.
AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their physician if the diarrhea becomes severe.
Patients taking AMITIZA may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their physician.
In clinical trials of AMITIZA (24 mcg) in patients with Chronic Idiopathic Constipation, the most common adverse reactions (incidence > 4%) were nausea (29%), diarrhea (12%), headache (11%), abdominal pain (8%), abdominal distention (6%), and flatulence (6%).
In clinical trials of AMITIZA (8 mcg) in patients with Irritable Bowel Syndrome with Constipation, the most common adverse reactions (incidence > 4%) were nausea (8%), diarrhea (7%), and abdominal pain (5%).
Please see complete Prescribing Information at www.amitiza.com.
AMITIZA is co-marketed by Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc.
AMITIZA® is a registered trademark of Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., a specialty biopharmaceutical company based in Bethesda, Md., focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which are bio-lipids that occur naturally in the human body, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals’ chairman and chief executive officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding chief executive officer and advisor, international business development.
Sucampo Pharmaceuticals is marketing AMITIZA (lubiprostone) in the U.S. for Chronic Idiopathic Constipation in adults and Irritable Bowel Syndrome with Constipation in adult women ≥ 18 years old, and is developing the drug for additional gastrointestinal disorders with large potential markets. In addition, Sucampo Pharmaceuticals has a robust pipeline of compounds with the potential to target underserved diseases affecting millions of patients worldwide. Sucampo Pharmaceuticals has two wholly owned subsidiaries: Sucampo Pharma Europe, Ltd. headquartered in Oxford, U.K., with a branch office in Basel, Switzerland, and Sucampo Pharma, Ltd., located in Tokyo and Osaka, Japan.
To learn more about Sucampo Pharmaceuticals and its products, visit www.sucampo.com.
Takeda Pharmaceuticals North America, Inc.
Based in Deerfield, 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 products for diabetes, insomnia, wakefulness and gastroenterology. The company 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.
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