Sucampo Announces Positive Results From A Japanese Phase 2b Dose-Ranging Study Of AMITIZA(R) For Chronic Idiopathic Constipation

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 19 Sep 2008 - 7:00 PDT

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Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced results of its phase 2b dose-ranging study of AMITIZA® (lubiprostone) in patients with Chronic Idiopathic Constipation (CIC), conducted in Japan. The study demonstrated a statistically significant increase in mean change in spontaneous bowel movements (SBM) from baseline after one week on treatment (p<0.0001), the study's primary endpoint, for patients taking AMITIZA 24 micrograms twice daily versus placebo.

AMITIZA 24 mcg also demonstrated statistically significant improvement versus placebo for several secondary endpoints, including change in SBM after Week 2, mean weekly SBM, percentage of patients having first SBM within 24 and 48 hours, degree of straining and stool consistency, abdominal bloating, abdominal discomfort, global assessment of severity of constipation, global assessment of treatment efficacy as well as a quality of life evaluation of treatment satisfaction.

A lower dose level of AMITIZA, 16 mcg twice daily, also demonstrated statistically significant improvements over placebo in the primary endpoint and some of the secondary endpoints.

The randomized, parallel group, double-blind, placebo-controlled, multi-center phase 2b dose-ranging study compared the dose response of oral AMITIZA with that of placebo in Japanese patients diagnosed with Chronic Idiopathic Constipation. The study evaluated 170 patients who were randomized to one of three twice-daily doses of AMITIZA (8, 16 or 24 mcg) or placebo.

In general, AMITIZA was well-tolerated. The most commonly reported adverse events (reported in greater than 5% of patients) included diarrhea, nausea, and stomach discomfort, and are consistent with previously reported AMITIZA data.

"These results provide further validation of the safety and efficacy of AMITIZA," said Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' Chairman and Chief Executive Officer. "While AMITIZA has created a unique position in the U.S. marketplace with approvals for both CIC in adults and Irritable Bowel Syndrome with Constipation (IBS-C) in adult women, international approvals are an important component in Sucampo's long-term growth strategy. The success of this trial allows Sucampo to plan for pivotal phase 3 studies for the Japanese market as well as a marketing partner."

"Based on these results, we plan to commence phase 3 clinical trials in Japan by mid-2009, moving Sucampo closer to our milestone of filing for marketing authorization for AMITIZA in Japan for CIC," stated Gayle Dolecek, P.D., M.P.H., Sucampo Pharmaceutical's Senior Vice President of Research and Development, "We look forward to presenting the full results from this trial at an upcoming scientific meeting."

An end of phase 2 meeting with Japanese regulatory authorities has been scheduled to discuss the results of the phase 2 study and the proposed phase 3 program.

AMITIZA increases fluid secretion into the intestinal tract by activating specific chloride channels in cells lining the small intestine. This increased fluid level softens the stool, facilitating intestinal motility and bowel movements. In addition, AMITIZA improves symptoms associated with chronic idiopathic constipation, including straining, hard stools, bloating and abdominal pain or discomfort.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., a biopharmaceutical company based in Bethesda, MD, focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which are bio-lipids that occur naturally in the human body, 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 is marketing AMITIZA® (lubiprostone) 24 mcg in the U.S. for Chronic Idiopathic Constipation in adults and AMITIZA® (lubiprostone) 8 mcg in the U.S. to treat Irritable Bowel Syndrome with Constipation in adult women and is developing the drug for additional gastrointestinal disorders with large potential markets. In addition, Sucampo Pharmaceuticals has a robust pipeline of compounds with the potential to target underserved diseases affecting millions of patients worldwide. Sucampo Pharmaceuticals has two wholly owned subsidiaries: Sucampo Pharma Europe, Ltd., headquartered in Oxford, UK, with a branch office in Basel, Switzerland, and Sucampo Pharma, Ltd., located in Tokyo and Osaka, Japan. To learn more about Sucampo Pharmaceuticals and its products, visit http://www.sucampo.com.

About AMITIZA (lubiprostone) for Chronic Idiopathic Constipation and Irritable Bowel Syndrome with Constipation

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.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Sucampo Pharmaceuticals 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. Forward-looking statements include statements about our plans for a phase 3 clinical trial in Japan and our international growth strategies. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors described in Sucampo Pharmaceuticals' filings with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K for the year ended December 31, 2007 and other periodic reports filed with the SEC. 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, Sucampo Pharmaceuticals specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise.

AMITIZA® is a registered trademark of Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc.