Sucampo announces positive results from lubiprostone phase 3 trial on OBD

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced positive top-line results from an open-label phase 3 clinical trial designed to evaluate the long-term safety and efficacy of lubiprostone in opioid-induced bowel dysfunction (OBD) patients with chronic, non-cancer-related pain.    

In this open-label study (439 subjects treated) of 36 weeks' duration there were no reported serious adverse events that were considered drug-related. The most common adverse events (greater than 5%) that arose during the trial were diarrhea (9.6%), nausea (8.9%), upper respiratory infection (6.4%) and back pain (5.2%). The most common adverse events that were considered treatment-related (greater than 2%) were nausea (5.0%) and diarrhea (4.6%). Adverse events were categorized in the study as mild, moderate or severe. Severe events of nausea and diarrhea each occurred in 0.5% of patients. Overall, only 3.4% and 5.2% of patients withdrew from the trial due to lack of efficacy or adverse events, respectively, over the 9-month treatment period. Additionally, treatment with lubiprostone demonstrated consistent improvements over baseline with respect to bowel frequency rates and other OBD-related symptoms at each timepoint measured throughout the study.

"We are highly pleased with the long term safety profile and efficacy observed in this phase 3 trial of lubiprostone in OBD," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chair, CEO and CSO of Sucampo. "These data will be an important part of our supplemental new drug application (sNDA). With these data and those of the previously completed phase 3 trials, we now have all the necessary data for submission and are preparing to file the sNDA mid-year with a request for priority review."

Detailed results from this open-label phase 3 trial will be submitted for presentation at an appropriate medical meeting and for publication in an appropriate peer-reviewed journal.