Phase III trials of Movantik for OIC published in NEJM-AstraZeneca

AstraZeneca has announced that the New England Journal of Medicine has published results of two pivotal Phase III studies � KODIAC-4 and KODIAC-5 of Movantik (naloxegol), an investigational treatment for Opioid-induced Constipation (OIC). Primary endpoint data from the KODIAC-4 and -5 studies showed that more OIC patients treated with naloxegol 25 mg had a consistent response of increased spontaneous bowel movements (SBMs) through 12 weeks of treatment compared to placebo [44% vs. 29% and 40% KODIAC-4 vs. 29% KODIAC-5)].

The 12.5 mg dose in KODIAC-5 did not show statistical significance for the primary endpoint. The 25 mg dose also demonstrated a higher response rate through 12 weeks of treatment compared to placebo in patients with laxative inadequate response, a secondary endpoint. Results for an additional secondary endpoint showed that patients taking naloxegol 25 mg in the KODIAC-4 and KODIAC-5 studies were likely to have a first post-dose spontaneous bowel movement 25-30 hours sooner than placebo. See: "Naloxegol for Opioid-Induced Constipation in Patients with Noncancer Pain" William D. Chey et al. N Engl J Med 2014 v370 p2387-2396 June 19, 2014 DOI: 10.1056/NEJMoa1310246