AstraZeneca today announced positive top-line results from two Phase 3 trials of naloxegol in patients with non-cancer related pain and opioid-induced constipation (OIC). Naloxegol is an oral peripherally-acting, mu-opioid receptor antagonist.
KODIAC-04 and -05 were multicenter, randomized, double-blind, placebo-controlled pivotal trials of 12 weeks duration evaluating 12.5mg and 25mg naloxegol administered once-daily. The primary endpoint in both trials was percentage of OIC responders vs. placebo over 12 weeks of treatment where a responder was defined as having at least three Spontaneous Bowel Movements (SBM) per week, with at least one SBM per week increase over baseline, for at least nine out of 12 weeks, and at least three out of the last four weeks.
In KODIAC-04, both naloxegol doses (12.5mg and 25mg) demonstrated statistically significant results for the primary endpoint. P-values were 0.015 and 0.001 respectively. In KODIAC-05, the 25mg dose demonstrated a statistically significant result for the primary endpoint but the 12.5mg dose did not. P-values were 0.202 for 12.5mg and 0.021 for 25mg.
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