Jul 19 2013
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced the initiation of Phase 3 efficacy studies of bevenopran (previously known as CB-5945) in patients with chronic non-cancer pain and opioid-induced constipation (OIC).
“Effective management of OIC is extremely important for the millions of patients who need opioids to manage chronic non-cancer pain and there are limited treatment options currently available”
The Phase 3 program, ASCENT, includes three identically-designed studies that will enroll approximately 600 patients each (1,800 total) designed to evaluate the efficacy and safety of bevenopran (0.25 mg orally twice daily) vs. placebo. The ASCENT program also includes a 1,400-patient one-year, placebo-controlled safety study which was initiated in October 2012.
"Effective management of OIC is extremely important for the millions of patients who need opioids to manage chronic non-cancer pain and there are limited treatment options currently available," said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. "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."
The primary endpoint of the studies is the proportion of spontaneous bowel movement (SBM) responders over a 12-week treatment period. The Phase 3 efficacy trials also include, as a secondary endpoint, a patient reported outcome (PRO) measurement tool that was developed and validated using data from the Phase 2 studies of bevenopran. This measure, known as Chronic Opioid-Related Gastrointestinal Symptoms Scale (CORGISS), assesses GI symptoms associated with chronic opioid therapy.
Cubist Pharmaceuticals, Inc.