Sucampo presents phase 3 trial results of lubiprostone in non-cancer pain patients with OBD at DDW 2010

May 11 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.

“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.”

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.