Biopharmaceutical company Cubist Pharmaceuticals has begun enrolment in Phase III efficacy studies designed to assess Bevenopran, previously known as CB-5945, in the treatment of opioid-induced constipation (OIC).
ASCENT is the Phase III programme comprising three identically designed studies to assess the safety and efficacy profile of bevenopran 0.25mg orally twice daily against placebo in approximately 600 patients each.
A 1,400-patient placebo-controlled safety study with one year period, initiated in October 2012, is also a part of ASCENT.
Cubist Pharmaceuticals chief scientific officer Dr Steven Gilman said effective management of OIC is important for patients in need of opioids to manage chronic non-cancer pain and currently there are limited treatment options available.
"We believe bevenopran has the potential to be an important option for managing constipation and related symptoms in patients taking chronic opioids for pain management," Gilman said.
The Phase III efficacy trial’s primary endpoint is the proportion of spontaneous bowel movement (SBM) responders over a treatment period of 12 weeks.
The patient reported outcome (PRO) measurement tool developed and validated using data from the Phase II studies of bevenopran is the secondary endpoint.
Known as Chronic Opioid-Related Gastrointestinal Symptoms Scale (CORGISS), the measure weighs up GI symptoms associated with chronic opioid therapy.