In the multicenter, open-label extension study reported no serious adverse events that were considered drug-related.
The most common adverse events that arose during the trial were diarrhea (9.6%), nausea (8.9%), upper respiratory infection (6.4%) and back pain (5.2%).
The adverse events that were considered treatment-related (greater than 2%) were nausea (5.0%) and diarrhea (4.6%).
Sucampo chair, CEO and CSO Ryuji Ueno said the long term safety profile and efficacy were observed in this Phase 3 trial of lubiprostone in OBD.
"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," Ueno added.