Pill Identifier App

Data from Clinical Trial Examining Lubiprostone for the Treatment of Opioid-induced Bowel Dysfunction Presented at Digestive Disease Week Conference

BETHESDA, Md.--(BUSINESS WIRE)--May 10, 2010 - Sucampo Pharmaceuticals, Inc. today announced the presentation of results from a phase 3 clinical trial investigating the use of lubiprostone in non-cancer pain patients with Opioid-induced Bowel Dysfunction (OBD). These results were the subject of an oral presentation at the Digestive Disease Week (DDW) 2010 conference in New Orleans, Louisiana, on May 5, 2010.

Byron Cryer, M.D., the John C. Vanatta III Professor of Medicine at the University of Texas, Southwestern, in Dallas, Texas, who was an investigator in the trial and presented the data at DDW, said, “Opioid-induced Bowel Dysfunction in patients with chronic non-cancer pain is a serious problem. In the Phase 3 results of this study presented here, some patients received relief from constipation without a reduction in their pain medication.”

Gayle R. Dolecek, P.D., M.P.H., Senior Vice President, Research & Development, Sucampo Pharmaceuticals, Inc., said, “We were pleased to see these data from the Phase 3 results of lubiprostone in this trial as we believe lubiprostone may represent a future treatment strategy for OBD patients if approved in this patient population.”

The results reported are from a randomized, double-blind, placebo-controlled phase 3 clinical trial (known as OBD0631) that assessed the safety and efficacy of lubiprostone (24 mcg twice daily) for the treatment of OBD in patients taking opioids for non-cancer pain. In this trial, patients with OBD were randomized to receive either lubiprostone 24 mcg gel capsules or matching placebo capsules twice a day every day for 12 weeks.

A total of 875 OBD patients with non-cancer pain were randomized into two identically designed phase 3 trials. The data reported at DDW are from one of these trials, in which statistical significance was achieved for the primary endpoint in one study (OBD0631), but not in the other study (OBD632). Statistically significant improvements were seen for eight of the 12 secondary endpoints in study OBD0631. In study OBD0632, statistically significant improvements were noted for two of 12 secondary endpoints.

Among the key results of the OBD0631 trial were:

 

  • The primary efficacy endpoint, the change from baseline in spontaneous bowel movement (SBM) frequency at Week 8 in patients without reduction in dose of study medication, achieved statistical significance (p=0.0226) for patients taking lubiprostone (n=167) compared to placebo (n=169).
  • Patients taking lubiprostone achieved a significantly (p=0.02) greater increase in the mean number of SBMs per week in eight of the 12 weeks of the trial, as compared to placebo patients.
  • The percentage of patients who achieved a SBM within 24 hours and 48 hours was significantly higher with lubiprostone as compared to placebo (p=0.0126 at 24 hours, and p=0.0360 at 48 hours).
  • Statistical significance was achieved for the overall change from baseline in constipation-associated symptom endpoints including: constipation severity (p=0.0006); stool consistency (p<0.0001); abdominal discomfort (p=0.0246); and, straining (p<0.0001).
  • The most commonly reported adverse events in this trial were nausea, diarrhea, and abdominal distension. Overall 4.6% of patients (3.2% placebo vs. 5.9% lubiprostone) discontinued due to an adverse event.

About the Trial Design

A total of 443 OBD patients enrolled at multiple sites in the U.S. and Canada were randomized into this double-blind, placebo-controlled phase 3 clinical trial and received one 24-mcg gel capsule of lubiprostone or placebo twice a day for 12 weeks. Patients in the trial were administered different opioid pain medications including fentanyl, methadone, morphine, and oxycontin.

AMITIZA® (lubiprostone) for Chronic Idiopathic Constipation in Adults and Irritable Bowel Syndrome with Constipation in Adult Women

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 old.

Important Safety Information

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 distension (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 www.amitiza.com.

Sucampo Pharmaceuticals

Sucampo Pharmaceuticals, Inc., an international 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.

Sucampo markets Amitiza® (lubiprostone) 24 mcg in the U.S. for chronic idiopathic constipation in adults and Amitiza 8 mcg in the U.S. to treat irritable bowel syndrome with constipation in adult women. Sucampo also is developing the drug for additional gastrointestinal disorders with large potential markets. In addition, Sucampo has a robust pipeline of compounds with the potential to target underserved diseases affecting millions of patients worldwide.

Sucampo Pharmaceuticals, Inc. has three wholly owned subsidiaries: Sucampo Pharma Europe, Ltd., located in the UK; Sucampo Pharma, Ltd., located in Japan; and Sucampo Pharma Americas, Inc., located in Maryland. To learn more about Sucampo Pharmaceuticals Inc. and its products, visit www.sucampo.com.

About Digestive Disease Week (DDW)

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 1 – 5, 2010, in New Orleans. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

Sucampo Forward Looking Statement

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, including those 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, 2009 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 does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise, except as required by law.

 

Contact: Sucampo Pharmaceuticals, Inc.
Kate de Santis, 240-223-3834
kdesantis@sucampo.com
or
Westwicke Partners, LLC
John Woolford, 443-213-0506
john.woolford@westwickepartners.com

 

Posted: May 2010

View comments

Hide
(web1)