AstraZeneca's naloxegol meets endpoints; EMA validates Gilead's sofosbuvir MAA

Anglo-Swedish drug major AstraZeneca (LSE: AZN) yesterday (May 21) presented the results of two pivotal Phase III studies of naloxegol showing the 25mg dose of the investigational drug met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studies for the treatment of opioid-induced constipation (OIC), at the Digestive Disease Week (DDW) meeting in Orlando, Florida, USA.

The Phase III studies, KODIAC-04 and -05, were 12-week, multicenter, randomized, double blind, placebo-controlled pivotal trials that evaluated 12.5mg and 25mg 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.