ORLANDO, FLA. — 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.
NOTES TO EDITORS
Naloxegol is part of the exclusive worldwide license agreement announced on 21 September 2009, between AstraZeneca and Nektar Therapeutics (NASDAQ:NKTR). Naloxegol was developed using Nektar's oral small molecule polymer conjugate technology.
About Opioid-Induced Constipation
Opioids bind to specific proteins called opioid receptors. When the opioids bind to certain opioid receptors in the gastrointestinal (GI) tract, constipation may occur. Opioid-induced constipation is a result of increased fluid absorption and lower GI motility due to opioid receptor binding in the gastrointestinal tract.
Globally, approximately 40–50% (28-35 million) of patients taking opioids for long-term pain develop constipation. About 40–50% (11-18 million) of those OIC sufferers achieve the desired treatment outcomes with current options that include over-the-counter and prescription laxatives.
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