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Sucampo Pharma, Ltd., A Subsidiary of Sucampo Pharmaceuticals, Inc., Announces Start of Phase 2b Study in Japan to Evaluate Lubiprostone for Chronic Idiopathic Constipation

Posted on: Thursday, 29 November 2007, 12:00 CST

Sucampo Pharma Ltd. (SPL), a wholly-owned Japanese subsidiary of Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP), a specialty pharmaceutical company developing prostone-based therapies for age-related and other diseases, today announced the initiation of a multi-center Phase 2b dose-ranging study in Japan to evaluate the safety and efficacy of lubiprostone for adult Chronic Idiopathic Constipation.

The randomized, parallel group, double-blind, placebo-controlled study will compare the dose response of oral lubiprostone with that of placebo in Japanese patients diagnosed with Chronic Idiopathic Constipation. Approximately 160 patients are expected to be enrolled at 13 sites. Patients will be randomized to one of three twice-daily doses of lubiprostone (8 mcg, 16 mcg or 24 mcg capsule) or placebo. Patients will be dosed for 14 days. The primary endpoint of the study will be the number of spontaneous bowel movements after one week on treatment.

"Initiation of this study is a key step in our AMITIZA® commercialization strategy, which includes actively pursuing geographical expansion in addition to the expansion of indications and dosage formulations," said Ryuji Ueno, M.D., Ph.D., Ph.D., founder, chairman and chief executive officer of Sucampo Pharmaceuticals.

Said Kunihiko Soneoka, president and chief executive officer of Sucampo Pharma, Ltd., "It is a great step forward for SPL to have an opportunity to study the safety and efficacy of lubiprostone in Japanese patients, who may be unsatisfied with traditional treatment options for this condition, including lifestyle and dietary changes, laxatives and stool softeners."

Sucampo Pharmaceuticals developed and co-markets lubiprostone (24 mcg gel capsules) in the United States as AMITIZA, the only commercially available prescription treatment for Chronic Idiopathic Constipation in adults. More than 750,000 AMITIZA prescriptions have been written since the product was approved by the U.S. Food and Drug Administration and launched in the United States in April 2006.

About Chronic Idiopathic Constipation

Constipation, one of the most common digestive complaints in the U.S., affects up to 42 million adults, and is the cause of 2.5 million visits to physicians and 92,000 hospitalizations annually. 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.

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; incomplete evacuation; prolonged time to stool; or the need for manual maneuvers to pass stool. Patients having two or more of the above symptoms for at least six months are considered chronic.

About AMITIZA (lubiprostone) 24 mcg Twice Daily 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.

AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and be instructed to inform their physician if the diarrhea or nausea 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 Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., a specialty pharmaceutical company based in Bethesda, Md., focuses on the discovery, 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 Sucampo Pharmaceuticals and its products, visit www.sucampo.com.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Sucampo Pharmaceuticals, Inc. are forward-looking statements made under the provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the words "project,""believe,""anticipate,""plan,""expect,""estimate,""intend,""should,""would,""could,""will,""may" or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the results of clinical trials with respect to Sucampo Pharmaceuticals' products under development; the timing and success of submission, acceptance and approval of regulatory filings; Sucampo Pharmaceuticals' dependence on the commercial success of AMITIZA; Sucampo Pharmaceuticals' ability to obtain additional funding required to conduct its discovery, development and commercialization programs; Sucampo Pharmaceuticals' dependence on its co-marketing alliance with Takeda Pharmaceutical Company Limited; and Sucampo Pharmaceuticals' ability to obtain, maintain and enforce patent and other intellectual property protection for its discoveries. These and other risks are described in greater detail in the "Risk Factors" section of Sucampo Pharmaceuticals' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the quarter ended June 30, 2007. Any forward-looking statements in this press release represent Sucampo Pharmaceuticals' views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Sucampo Pharmaceuticals anticipates that subsequent events and developments will cause its views to change. However, while Sucampo Pharmaceuticals may elect to update these forward-looking statements publicly at some point in the future, it specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise.

Source: Business Wire

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