Lubiprostone Increases Spontaneous Bowel Movement Frequency and Improved Symptoms in Patients With Chronic Constipation

HONOLULU -- Sucampo Pharmaceuticals, Inc. announced study results with lubiprostone, an investigational compound for the treatment of chronic idiopathic constipation. In this study, 61 percent of patients taking lubiprostone experienced a prompt effect, reporting at least one spontaneous bowel movement (SBM) within the first 24 hours of treatment versus 31 percent of patients receiving placebo. Patients taking lubiprostone also experienced a sustained effect, reporting an increased number of SBMs per week. These data were presented at the 70th annual meeting of the American College of Gastroenterology (ACG). Additional studies found that lubiprostone significantly reduced the severity of constipation.

Lubiprostone is a novel chloride-channel activator that works by increasing fluid secretion in the intestines to treat constipation. A new drug application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in March 2005 to market lubiprostone for the treatment of chronic idiopathic constipation and associated symptoms in adults. In addition, a Phase III clinical development program for lubiprostone in patients with constipation-predominant irritable bowel syndrome (C-IBS) was recently initiated.

Study Designs
A Phase III multicenter, parallel-group, double blind, randomized, placebo-controlled study examined 237 subjects who had a history of fewer than three SBMs per week and at least a six-month history of other symptoms of chronic constipation. The subjects were randomized to receive either 24 micrograms of lubiprostone or a matching placebo tablet twice daily for a 28-day period.

It was found that patients in the lubiprostone group increased to 5.89 SBMs within the first week, versus 3.99 in the placebo group. Additionally, patients in the lubiprostone group experienced a decreased degree of straining and improvement in stool consistency and constipation severity. These effects were sustained through the duration of the study. Also, more than 61 percent of participants experienced at least one SBM in the first 24 hours (versus 31.4 percent in the placebo-treated subjects). The results of this study were confirmed in Phase III patient assessments of the effects of lubiprostone, where subjects were asked to evaluate bowel movements and various symptoms of chronic constipation (e.g., severity, bloating and discomfort, consistency and straining).

Long-term open-label data was also presented at ACG that evaluated lubiprostone in 306 subjects over a six-month period. Patients reported continued relief from many symptoms associated with constipation, including constipation severity, bloating and abdominal discomfort.

In these studies, the most common side effects were nausea, diarrhea and headache; these were generally classified as mild to moderate in severity.

Lubiprostone is an investigational compound currently being evaluated by the FDA for the treatment of chronic idiopathic constipation and will be jointly marketed by Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc. when the product is approved.

About Chronic Constipation
Constipation, defined as infrequent and difficult passage of stool, is one of the most common digestive complaints. It is reported that constipation affects over 30 million people in the United States and is the cause of 2.5 million visits to physicians and 92,000 hospitalizations annually. The condition becomes chronic when a person has two or more defining symptoms (including straining during bowel movements, lumpy or hard stool, sensation of incomplete evacuation or fewer than three bowel movements a week), for at least 12 nonconsecutive weeks over a period of 12 months. While chronic constipation is a common problem, currently available treatments have been far from satisfactory as they often fail to control symptoms adequately, produce problematic side effects, or lose effectiveness over time.

Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a pharmaceutical company that concentrates on developing compounds from its proprietary functional fatty acid technology platform, which consists of exclusive rights in the Americas to a portfolio of more than 650 patents.

Takeda Pharmaceuticals North America, Inc.
Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan.

Source: Sucampo Pharmaceuticals, Inc.

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