Optimistic Results Announced by Sucampo from Lubiprostone on OBD

Sucampo Pharmaceuticals, Inc. introduced optimistic top-line results from an open-label phase 3 clinical trial built to evaluate the long-term security and performance of lubiprostone in opioid-induced bowel dysfunction (OBD) affected individuals with chronic, non-cancer-related pain.

With this open-label study of 36 weeks period there were no reported significant adverse effects that were regarded drug-related. Some of the most common adverse effects that in fact came about through the trial were nausea, diarrhea, and back pain and upper respiratory infection.

The more common side-effects which were considered treatment-related were actually nausea and diarrhea. Adverse events were organized in the study as mild, moderate or severe. Acute events of nausea and diarrhea each took place in 0.5% of affected individuals. Overall, only 3.4% and 5.2% of affected individuals withdrew from the trial due to absence of efficacy or negative effects, respectively, over the 9-month cure period.

"We are extremely delighted with the long run safety traits and efficacy seen in this particular phase 3 trial of lubiprostone in OBD," said Ryuji Ueno, CEO of Sucampo. Complete results using this open-label phase 3 trial will be provided for identification at an appropriate medical seminar as well as for journal in an appropriate peer-reviewed record.