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AMITIZA is the only widely available FDA-approved prescription treatmentoption that can provide overall symptom relief for the millions of adult womenin the U.S. with IBS-C.
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AMITIZA has a mechanism of action that works locally in the intestine toincrease fluid secretion, resulting in increased passage of stool andalleviating symptoms associated with Chronic Idiopathic Constipation.Although it is not well understood how AMITIZA works to reduce symptoms inpatients with IBS-C, ex vivo animal studies suggest that AMITIZA stimulatesrecovery of mucosal barrier function by restoring tight junction proteincomplexes.
"The effects of IBS-C can be debilitating and far-reaching -- affectingmany aspects of a person's life," said Charles Baum, M.D., gastroenterologist,executive medical director, Gastroenterology and Internal Medicine, at TakedaPharmaceuticals North America, Inc. "The availability of AMITIZA makes itpossible for appropriate patients to receive a widely available prescriptionmedication that can be an important tool to help treat this condition."
"I am very pleased with the quick commercial launch of AMITIZA 8 mcg forthis particular indication as it could provide a treatment option to manyadult 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 theU.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 discomfortor pain, bloating and changes of bowel habits such as constipation and/ordiarrhea. 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 (notnecessarily consecutive) over a 12-month period. Although people with IBS-Creport many of the symptoms associated with constipation, the presence ofabdominal discomfort or pain is what differentiates IBS-C from chronicconstipation. IBS is approximately two to two-and-a-half times more prevalentin women than men.
About AMITIZA(R) (lubiprostone) for Chronic Idiopathic Constipation andIBS-C Indication
AMITIZA(R) (lubiprostone) is indicated for the treatment of ChronicIdiopathic Constipation (24 mcg) in adults and for Irritable Bowel Syndromewith Constipation (8 mcg) in women 18 years and older.
Important Safety Information
AMITIZA is contraindicated in patients with known or suspected mechanicalgastrointestinal obstruction. Patients with symptoms suggestive of mechanicalgastrointestinal obstruction should be thoroughly evaluated by the treatingphysician to confirm the absence of such an obstruction prior to initiatingAMITIZA treatment.
The safety of AMITIZA in pregnancy has not been evaluated in humans.AMITIZA should be used during pregnancy only if the benefit justifies thepotential risk to the fetus. Women who could become pregnant should have anegative pregnancy test prior to beginning therapy with AMITIZA and should becapable of complying with effective contraceptive measures.
Patients taking AMITIZA may experience nausea. If this occurs, concomitantadministration of food with AMITIZA may reduce symptoms of n