Data From Clinical Trial Examining Lubiprostone For The Treatment Of Opioid-induced Bowel Dysfunction Presented At Digestive Disease Week Conference

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







- 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. 4%) were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).


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 ddw.

Source
Sucampo Pharmaceuticals, Inc.


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