Analysis of Phase III trial of Movantik (naloxegol) in Opioid Constipation-AstraZeneca

Further analysis of the Phase III KODIAC-04, KODIAC-05 and KODIAC-08 studies showed that Movantik (naloxegol), from AstraZeneca, had a similar incidence of adverse events (AEs) among elderly patients with opioid-induced constipation (OIC) and chronic non-cancer pain as compared to placebo or usual care. The study evaluated the effects of daily oral administration of Movantik 12.5 mg or 25 mg vs placebo among outpatients 65 years and older with opioid-induced constipation (OIC) and chronic non-cancer pain.

The incidence of AEs reported among patients taking Movantik was similar to those taking placebo or usual care. Safety results among this subset were generally consistent with those seen in the overall patient populations from Phase III studies. The most common gastrointestinal (GI) AEs in older patients taking naloxegol were diarrhea, vomiting, nausea, and abdominal pain. Data were presented at Digestive Disease Week (DDW) 2015 in Washington, D.C.