BETHESDA , Maryland , September 21/PRNewswire/ --

 Study results demonstrating that AMITIZA(TM) (lubiprostone), the first selective chloride channel activator for the treatment of chronic idiopathic constipation, was effective and well-tolerated in relieving symptoms of chronic idiopathic constipation in the elderly population were presented at the Neurogastroenterology and Motility 2006 Joint International Society Meeting in Boston . An estimated 30 million Americans are affected by constipation, and it is most prevalent in adults over the age of 65.

"Constipation is a common and bothersome gastrointestinal condition and is particularly prevalent among the elderly population 65 years of age and older. Despite its prevalence, these elderly patients have limited treatment options and AMITIZA presents a new therapeutic option for this underserved population," said Dr. John Morley, MBCh, Director of Geriatrics, Interim Director of Endocrinology, St. Louis University Medical School , St. Louis , MO.

AMITIZA has a novel mechanism of action that works by increasing fluid secretion in the small intestine by activating ClC-2 chloride channels, and thereby increasing the passage of stool and improving symptoms associated with chronic constipation. AMITIZA is the only prescription medication for chronic idiopathic constipation that has been approved for use in older adults, and can be used for longer than two weeks.

AMITIZA, approved by the U.S. Food and Drug Administration (FDA) in January 2006, was developed by Sucampo Pharmaceuticals, Inc., and is jointly marketed in the United States by Sucampo and Takeda Pharmaceuticals North America, Inc.

Study Design

To evaluate symptom relief and the safety profile of AMITIZA in the elderly adult population, data from three short-term (3-4 weeks), well-controlled clinical studies were pooled together to obtain an adequate group of adults over age 65. In total, 57 patients were included in the analysis: 26 participants received AMITIZA 24 mcg taken twice daily, and 31 participants received placebo.

The findings reveal that mean changes from baseline in spontaneous bowel movements (SBMs) were significantly greater in the group treated with AMITIZA (4.6-5.4 additional SBMs per week) versus the placebo group (1.3-2.3 SBMs per week) during weeks 1, 3 and 4 (P less than or equal to 0.0286). Improvements in both stool consistency and bowel-straining rating were also observed in patients taking AMITIZA over those taking placebo. Additionally, fewer patients in the AMITIZA group experienced adverse events (46.2%) compared to placebo-treated patients (61.3%), a result that was reversed in the non-elderly subgroup (65.7% AMITIZA vs. 40.1% placebo).

About AMITIZA

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 (greater than or equal to 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.

Source: Sucampo Pharmaceuticals, Inc.

 (22/9/06)