About Amitiza? (lubiprostone)

About Amitiza

Amitiza, approved by the U.S. Food and Drug Administration (FDA) in January 2006 for the treatment of chronic idiopathic constipation in adults, is an oral treatment that works by increasing fluid secretion in the small intestine by activating ClC-2 chloride channels, and thereby increasing the passage of the stool and improving symptoms associated with chronic idiopathic constipation.

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∞.

Effective And Predictable Relief For Adults Living With Chronic Idiopathic Constipation

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28 Apr 2006

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 Amitiza 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."

http://www.medilexicon.com/medicalnews.php?newsid=42285∞

Amitiza? (lubiprostone) May Help Improve Symptoms Of Irritable Bowel Syndrome With Constipation

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30 May 2006

A new study found that AMITIZA? (lubiprostone) may help relieve the symptoms associated with constipation-predominant Irritable Bowel Syndrome (IBS-C). IBS is a condition that affects nearly 30 million people in North America and accounts for 25-50 percent of referrals to gastroenterologists. The study was presented today at Digestive Disease Week, the largest annual meeting of digestive disease specialists.

?The results of this study suggest that AMITIZA may help improve several of the most frequently reported symptoms of IBS-C, including abdominal pain, bloating and discomfort,? said John Johanson, M.D., primary investigator and clinical associate professor, University of Illinois College of Medicine. ?There are several additional studies underway that further explore the uses of AMITIZA in this patient population and we look forward to learning the findings.?

AMITIZA is a novel selective chloride channel activator that has been shown to be effective and well-tolerated in a number of well-controlled clinical trials in patients with chronic idiopathic constipation. AMITIZA was approved for use for chronic idiopathic constipation in adults on January 31, 2006. This is the first time AMITIZA has been tested exclusively in the IBS-C population.

About the Study

In a double-blind, placebo-controlled, dose-ranging study, approximately 200 patients with diagnosed IBS-C (per the Rome II criteria) were randomized to receive placebo or AMITIZA (8, 16 or 24 micrograms) twice-daily for 12 weeks. In an electronic diary, patients recorded data related to dosing, side effects and IBS-C symptoms including bloating, abdominal pain/discomfort, frequency of and straining during bowel movements, stool consistency and rescue medication use.

Significant improvements versus placebo were observed for at least two of the three months for abdominal pain/discomfort, abdominal bloating, frequency of spontaneous bowel movements (SBM), stool consistency, bowel straining and assessments of constipation severity. Comparisons between the groups revealed that during the first and second months, the improvements in abdominal discomfort/pain and SBM frequency rates were more than doubled in all AMITIZA groups.

Overall, the improvements were typically highest in the highest AMITIZA dose group (48 micrograms/day). Dose-dependent trends were also seen for adverse events, with incidence and drop-out rates rising with the dose of AMITIZA.

http://www.medilexicon.com/medicalnews.php?newsid=44238∞

Takeda And Tap To Promote Sucampo's Amitiza In The US For Chronic Idiopathic Constipation

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01 Mar 2007

Takeda Pharmaceuticals North America, Inc. ("Takeda") and TAP Pharmaceutical Products Inc. ("TAP") has announced an agreement with TAP to promote Sucampo Pharmaceuticals, Inc.'s ("Sucampo") AMITIZA? (lubiprostone) approved for the treatment of chronic idiopathic constipation in adults in the United States. Developed by Sucampo, AMITIZA has been jointly promoted by Sucampo and Takeda since its approval by the U.S. Food and Drug Administration.

The agreement was signed and became effective January 31, 2007, with TAP detailing to begin March 2, 2007. The agreement is renewable by mutual agreement upon expiry of the initial term on March 31, 2009. Takeda will pay a detailing fee to TAP. Other conditions of the agreement were not disclosed.

TAP will now promote AMITIZA to gastroenterologists and primary care physicians to whom they are currently promoting Prevacid? (lansoprazole), and will replace the contract sales force currently used by Takeda. Takeda's sales force will continue to promote AMITIZA to gastroenterologists and primary care physicians as well.

"With this agreement, Takeda and Sucampo gain an experienced partner and will be able to leverage TAP's premier gastroenterology and primary care sales forces to help bring AMITIZA to the significant number of adults in the U.S. suffering from chronic idiopathic constipation," said Mark Booth, president of Takeda Pharmaceuticals North America, Inc. "This is a good strategic fit for Takeda as we continue to build our U.S. presence."

"This partnership will leverage both companies' strong primary and specialty care sales organizations to better serve the unique needs of our patients," said Alan MacKenzie, president of TAP Pharmaceutical Products Inc. "It allows TAP to build upon its longstanding commitment to and expertise in serving the primary care and gastroenterology communities."

"The combination of Takeda and TAP adds a new dimension to the U.S. distribution strategy for AMITIZA," said Sucampo Founder and Chief Executive Officer Ryuji Ueno, M.D., Ph.D., Ph.D. "We believe this new arrangement, which now includes TAP's sales force, will enhance the delivery of the message of AMITIZA to physicians and patients."
http://www.medilexicon.com/medicalnews.php?newsid=63893∞

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