Global pharmaceutical company Sucampo Pharmaceuticals Inc (SCMP: Quote) Thursday revealed 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 patients with chronic, non-cancer-related pain.
The company stated that the open-label study conducted over a period of 36 weeks did not reveal any serious adverse events that were considered drug-related. 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.
"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
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by RTT Staff Writer
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