Naldemedine Demonstrates Efficacy in Pivotal Phase 3 OIC Study
Compose I, a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, is part of the global comprehensive COMPOSE development program for naldemedine in patients with OIC and cancer or chronic non-cancer pain. COMPOSE I was designed to evaluate the efficacy and safety of naldemedine vs. placebo in 547 OIC patients with chronic non-cancer pain receiving opioid therapy for ≥3 months and on a stable opioid dose for ≥4 weeks. The primary endpoint was the responder rate, defined as 9 positive response weeks or more out of the 12-week treatment period and 3 positive response weeks out of the last 4 weeks of the 12-week treatment period. A positive response week is defined as ≥3 spontaneous bowel movements (SBMs) per week and an increase from baseline of ≥1 SBM per week for that week.
Results from COMPOSE I showed that once-daily treatment with naldemedine significantly improved OIC compared to placebo, meeting the study's primary endpoint. In patients treated with naldemedine, 47.6% experienced an increase in the frequency of SBMs from baseline for ≥9 out of 12 weeks (including 3 out of the last 4 weeks) compared with 34.6% of patients on placebo over 12 weeks. Findings are currently being presented at the American Academy of Pain Medicine (AAPM) 2016 Annual Meeting in Palm Springs, CA.
The Company previously announced positive results from COMPOSE II and IV as well, stating that naldemedine met its primary and key secondary endpoints.
Naldemedine is an investigational, oral, peripherally acting mu-opioid receptor antagonist (PAMORA).
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