Ads creatively depict the predictable relief provided by the only commercially available prescription treatment for chronic idiopathic constipation in adults
DEERFIELD, IL – November 6, 2007 – Takeda Pharmaceuticals North America, Inc. and Sucampo Pharmaceuticals, Inc. today announced the launch of the first direct-to-consumer (DTC) advertising campaign for AMITIZA® (lubiprostone), the only commercially available prescription treatment for Chronic Idiopathic Constipation in adults. The “Move to AMITIZA” campaign illustrates that the predictable relief (defined as 57%-63% had a spontaneous bowel movement within 24 hours with AMITIZA vs. 32%-37% with placebo) provided by AMITIZA may allow people living with chronic idiopathic constipation to move throughout their day without letting their condition slow them down.
“This is welcome news for the millions of Americans who live with Chronic Idiopathic Constipation,” said Charles Baum, M.D., medical director, Gastroenterology at Takeda. “This condition remains largely undertreated, in part because only about one in four patients with Chronic Idiopathic Constipation ever visit a physician for treatment—either because people are embarrassed to talk about it, or because they may not be aware that prescription treatment options are available.”
The ads, targeting women age 40 years and older, will run in various print and broadcast outlets and encourage people with Chronic Idiopathic Constipation to visit their doctor.
“Through our research, we learned that people with chronic constipation feel the condition slows them down,” said Aimee Berner, marketing director, Gastroenterology at Takeda. “According to a nationwide survey conducted by Braun Research, 82 percent of women with chronic constipation have taken over-the-counter medications for relief; and nearly 60 percent of these women report that the treatments work only some of the time or not at all.”
Constipation, one of the most common digestive complaints in the U.S., affects up to 42 million adults, and is more prevalent in women than men. Based on a retrospective analysis, it is estimated that 12 million can be characterized as suffering from Chronic Idiopathic Constipation. Chronic Idiopathic Constipation is chronic constipation with no known cause. Older adults age 65 years and older are especially susceptible to constipation.
AMITIZA, developed by Sucampo Pharmaceuticals, is the first and only chloride channel activator for the treatment of Chronic Idiopathic Constipation in adults, regardless of age or gender. AMITIZA has a unique mechanism of action that may provide predictable relief to help people with Chronic Idiopathic Constipation.
For additional background about AMITIZA and Chronic Idiopathic Constipation, please log onto www.amitizapresskit.com .
About AMITIZA® (lubiprostone) 24 mcg BID for Chronic Idiopathic Constipation
AMITIZA® (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation in adults.
AMITIZA is contraindicated in patients with known 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. 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.
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.
In clinical trials, the most common adverse reactions (incidence > 4%) were nausea (29%), diarrhea (12%), headache (11%), abdominal pain (8%), abdominal distention (6%), and flatulence (6%).
For full prescribing information, visit www.amitiza.com .
AMITIZA® is a registered trademark of Sucampo Pharmaceuticals, Inc.
About Chronic Constipation
Constipation is one of the most common digestive complaints, and is the cause of 2.5 million visits to physicians and 92,000 hospitalizations annually. Constipation is defined as unsatisfactory defecation that is characterized by infrequent stools, difficult stool passage or both. Difficult stool passage includes: straining; hard or lumpy stools; difficulty passing stool; incomplete evacuation; prolonged time to stool; or the need for manual maneuvers to pass stool. Symptoms must persist for at least three consecutive months for the condition to be considered chronic.
Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., an emerging pharmaceutical company based in Bethesda, Md., focuses on the development and commercialization of drugs based on prostones, a class of compounds derived from functional fatty acids that occur naturally in the human body. The therapeutic potential of prostones 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’ first product, AMITIZA® (lubiprostone), received marketing approval from the FDA in January 2006 for the treatment of Chronic Idiopathic Constipation in adults. To learn more about the company 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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