October 21, 2008
Sucampo Europe Presents Long-Term Safety and Efficacy Data of Lubiprostone in Chronic Idiopathic Constipation
Sucampo Pharma Europe, Ltd., a wholly-owned subsidiary of Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP), today announced the results from three open-labeled, long-term (6 and 12 months) clinical trials of lubiprostone (AMITIZA(R)). These trials were conducted between November 2001 and January 2005 and the results were previously reported in the United States. These data demonstrate that lubiprostone provided significant improvements in subjective assessments of symptoms and was well tolerated in patients with Chronic Idiopathic Constipation (CIC). Statistically significant improvements in subjective assessments were seen in secondary endpoints including constipation severity, abdominal bloating and abdominal discomfort.
These results were presented by Raymond Panas, Ph.D., of Sucampo, at the 16th United European Gastroenterology Week (UEGW) conference being held in Vienna, Austria, from October 18 to 22, 2008, in a poster titled "Long-Term Safety and Efficacy of Lubiprostone for the Treatment of Chronic Idiopathic Constipation."
"As we have previously reported in the United States, oral lubiprostone has demonstrated a favorable efficacy and safety profile in longer-term use settings," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of Sucampo. "The drug delivers targeted, predictable relief to assist patients with chronic constipation."
The first trial was a 24-week, open-labeled extension to a 4-week double-blinded, pivotal trial that enrolled 308 patients. The second trial was a 48-week, open-labeled trial in 250 subjects, 82 of whom participated in a 7-week randomized withdrawal study period prior to the open-labeled phase of the study. The third trial was a 48-week open-labeled trial in 325 treatment-naive subjects. Subjects assessed treatment effectiveness, constipation severity, and abdominal symptoms of bloating and discomfort using a 5-point scale. Eligible subjects received oral lubiprostone 24 mcg twice daily for 6 or 12 months, as needed. Subjects could then remain on a daily dosing schedule or stop the study drug if the perceived need decreased or ceased. Subjects could return to study drug when needed, but were to restart dosing again of lubiprostone at 24 mcg twice daily. Investigators could also adjust the daily dose in response to exaggerated pharmacodynamic events or treatment-related adverse events. Periodic rescue medication use was permitted at the discretion of the investigator.
Lubiprostone (AMITIZA) was approved by the U.S. Food & Drug Administration in January 2006 for treatment of Chronic Idiopathic Constipation in adults and in May 2008 for the treatment of Irritable Bowel Syndrome with Constipation in adult women.
AMITIZA is co-marketed in the United States by Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc. All European rights to AMITIZA are held by Sucampo Pharma Europe, Ltd.
Lubiprostone works by increasing fluid secretion and motility in the intestine, thereby increasing the passage of the stool and alleviating symptoms associated with chronic idiopathic constipation.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., a biopharmaceutical company based in Bethesda, Maryland, 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 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 greater than or equal to 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 greater than 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 greater than 4%) were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).
Please see complete Prescribing Information at www.amitiza.com.
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. 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(R) is a registered trademark of Sucampo Pharmaceuticals, Inc.