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news.AstraZeneca has recruited first patient in a Phase III trial investigating the safety and efficacy of NKTR-118 as a treatment for opioid-induced constipation (OIC).
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The Phase III clinical programme include two 12-week randomized, placebo-controlled efficacy studies (with approximately 630 randomized patients each) and an open-label, randomized, long-term safety study with a ‘usual care’ comparator arm.
The studies are expected to compare response rate among placebo and two different doses of NKTR 118 with primary endpoint at 4 weeks.
AstraZeneca Global Medicines Development executive vice president Anders Ekblom said this is a key milestone for NKTR-118.
"We will put our knowledge and our effort into studying NKTR-118 as a potential effective new treatment option for Opioid Induced Constipation, which continues to be an area of unmet need in patients needing effective pain treatment," Ekblom said.