Synergy Initiates Phase 2 Study of SP-333

Synergy Pharmaceuticals

today announced the start of a phase 2 clinical trial to evaluate the safety and efficacy of SP-333, its second-generation GC-C agonist and once-daily oral treatment, in adult patients with opioid-induced constipation (OIC). The multi-center, randomized, double-blind clinical trial will compare a 4-week, dose-ranging regimen of SP-333 (1.0, 3.0 and 6.0mg) against placebo in adult patients taking opioid analgesics for chronic, non-cancer pain for at least three months. The study plans to enroll approximately 260 patients with OIC who have less than 3 spontaneous bowel movements (SBMs) per week and who experience constipation-related symptoms. The primary endpoint of the study is mean change from baseline in the number of SBMs