AstraZeneca (NYSE: AZN) today presented the results of two pivotal Phase III studies of naloxegol showing the 25 mg dose of the investigational drug met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studies. Data was presented at the Digestive Disease Week (DDW) meeting in Orlando, Florida. Naloxegol is a peripherally-acting mu-opioid receptor antagonist, which has been specifically designed for the treatment of opioid-induced constipation (OIC), a common and often debilitating side effect of prescription opioid pain medicines.
The Phase III studies, KODIAC-04 and -05, were 12-week, multicenter, randomized, double blind, placebo-controlled pivotal trials that evaluated 12.5 mg and 25 mg doses of naloxegol, administered once-daily. The primary endpoint in both trials was percentage of OIC responders, versus placebo, over 12 weeks of treatment. The secondary endpoints included the 12-week response rate in a laxative inadequate response population, the median time to first spontaneous bowel movement (SBM) and the number of days per-week with at least one bowel movement.
Plans for naloxegol will be finalized over the coming months, incorporating the outcome of ongoing discussions with health authorities in the US, EU and Canada.
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