Sucampo Announces Lubiprostone Data Presented At GASTRO 2009 UEGF/WCOG

Main Category: GastroIntestinal / Gastroenterology
Article Date: 29 Nov 2009 - 0:00 PDT

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Sucampo Pharma Europe, Ltd., and Sucampo Pharma Americas, Inc., subsidiaries of Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP), presented additional clinical data for lubiprostone (Amitiza®) at GASTRO 2009 UEGF/WCOG, the joint meeting of the United European Gastroenterology Federation (UEGF), the World Gastroenterology Organisation (WGO), the World Organisation of Digestive Endoscopy (OMED) and the British Society of Gastroenterology (BSG), in London. The data presented reflect additional analyses of already disclosed phase 2 and phase 3 clinical trials of lubiprostone in patients with chronic idiopathic constipation (CIC) and in patients diagnosed with or reporting irritable bowel syndrome with constipation (IBS-C).

Overall, the data analyses demonstrated that, in these trials, lubiprostone achieved a statistically significant response in patients with IBS-C as compared to placebo patients in a variety of symptomatic endpoints; demonstrated long-term efficacy through an overall improvement in constipation severity for up to 12 months in adult patients regardless of age, gender or race; and achieved a significant response among refractory constipation patients as compared to placebo.

Ryuji Ueno, M.D., Ph.D., Ph.D., Chief Executive Officer, Chief Scientific Officer and Founder of Sucampo Pharmaceuticals, Inc. said, "The analyses presented today provide further evidence of the long-term safety and efficacy of lubiprostone as a treatment for chronic idiopathic constipation in adults, regardless of age, gender or race, and as a treatment for patients suffering from irritable bowel syndrome with constipation."

Lubiprostone Demonstrates Efficacy in Adult Patients with Constipation Regardless of Age, Gender or Race (Poster #P1853)

Pooled data from two pivotal phase 3 placebo-controlled safety studies with a total of 479 subjects were reviewed to analyze efficacy in sub-populations determined by age (non-elderly=<65 years or elderly= ≥65 years), gender and race (non-white and white). The efficacy endpoints for spontaneous bowel movement (SBM) frequency, stool consistency and straining) were compared between placebo and lubiprostone 24 microgram (mcg) BID, or twice daily, groups within each sub-population.

Patients with CIC treated with lubiprostone 24 mcg BID experienced an improvement in SBM frequency, stool consistency and straining as compared to placebo patients. These improvements were seen regardless of age, gender or race.

Long-Term Efficacy of Lubiprostone Demonstrated in Patients with Constipation Regardless of Age, Gender or Race (Poster#P1851)

Pooled data from three phase 3 open-label studies with a total of 871 adult subjects were reviewed to analyze efficacy in sub-populations determined by age (non-elderly=<65 years or elderly= ≥65 years), gender and race (non-white and white). Change from baseline for constipation severity, abdominal bloating and abdominal discomfort was rated.

Patients treated with lubiprostone 24 mcg BID achieved sustained relief of constipation symptoms for up to 12 months of treatment and this effect was seen regardless of age, gender or race. In addition, statistically significant improvements were seen in abdominal discomfort and abdominal bloating regardless of race and gender.

Lubiprostone Initiates Improvements in Constipation Symptoms in Refractory Patients (Poster #P1852)

Pooled data of 265 subjects from two pivotal placebo-controlled phase 3 studies were assessed to analyse efficacy in patients who were refractory to other constipation therapies, meaning they failed to achieve adequate relief from those therapies. All patients in the studies had a diagnosis of constipation for at least 6 months prior to enrollment. Refractory patients were those who utilized other common constipation treatment regimens within the 90 days prior to enrollment and met the criteria for constipation upon enrollment.

In these studies, refractory patients treated with lubiprostone 24 mcg BID achieved significant relief of constipation symptoms and improved response compared to placebo patients. Lubiprostone 24 mcg BID was notably effective in those patients who failed to achieve results with contact laxatives, enemas or polyethylene glycol (PEG) solutions.

Use of Lubiprostone (24 mcg BID) in Patients with Irritable Bowel Syndrome with Constipation (Poster #P1850)

Pooled data from 184 patients from three placebo-controlled phase 3 and phase 2 clinical trials were assessed for SBM frequency, straining, stool consistency, constipation severity, abdominal discomfort and abdominal bloating. The pooled population for these analyses was a subset of IBS-C patients from two phase 3 constipation studies who received lubiprostone 24 mcg BID and reported having IBS-C and patients from a phase 2 IBS-C study who received 24 mcg BID and were diagnosed with IBS-C. A comparison analysis was made between those who received placebo and those who received lubiprostone 24 mcg BID.

In this analysis, patients treated with lubiprostone 24 mcg BID showed statistically significant improvements over placebo patients at all weeks in SBM frequency, abdominal discomfort, stool consistency, straining, constipation severity and abdominal bloating.

As previously announced, Swissmedic, the Swiss Agency for Therapeutic Products, has granted a marketing authorization for lubiprostone (Amitiza) 24 mcg gel capsule BID for the long-term treatment of patients with CIC.

About lubiprostone

Amitiza is a local activator of type-2 chloride channels in cells lining the small intestine. Amitiza increases fluid secretion into the intestinal tract. This increased fluid level softens the stool, facilitating intestinal motility and bowel movements. We believe the type 2 chloride channels also play an important role in the restoration of tight junction complexes and in the recovery of barrier function in the body.

Amitiza is a registered trademark of Sucampo Pharmaceuticals, Inc.

About AMITIZA (lubiprostone) for Chronic Idiopathic Constipation and Irritable Bowel Syndrome with Constipation in the U.S.

In the U.S., AMITIZA (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg twice daily) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg twice daily) in women ≥18 years of age and older.

AMITIZA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider 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. 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 healthcare provider.

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 healthcare provider if the diarrhea becomes severe.

Patients taking AMITIZA may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their healthcare provider. Some patients have discontinued therapy because of dyspnea.

In clinical trials of AMITIZA (24 mcg twice daily vs. placebo: N=1113 vs. N=316) in patients with Chronic Idiopathic Constipation, the most common adverse reactions (incidence >4%) were nausea (29% vs. 3%), diarrhea (12% vs. 1%), headache (11% vs. 5%), abdominal pain (8% vs. 3%), abdominal distention (6% vs. 2%), and flatulence (6% vs. 2%).

In clinical trials of AMITIZA (8 mcg twice daily vs. placebo: N=1011 vs. N=435) in patients with Irritable Bowel Syndrome with Constipation, the most common adverse reactions (incidence >4%) were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).

Please see complete Prescribing Information at http://www.amitiza.com.

Source
Sucampo Pharmaceuticals

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