Phase III trial of Naloxegol (AstraZeneca) confirms earlier safety studies in patients with Opioid-induced Constipation

New results from KODIAC-08, an open-label, randomised, 52-week, long-term safety trial of Naloxegol (naxolol), from AstraZeneca, in patients with non-cancer related pain and Opioid-induced Constipation, are similar to safety results seen in earlier Phase III studies. A total of 534 patients received Naloxegol daily for up to 52 weeks, while 270 patients received usual care. The most commonly reported AEs occurring more frequently on Naloxegol included abdominal pain, diarrhoea, nausea and headache. The trial reported no imbalances in serious adverse events.

In addition, there were a low number of major adverse cardiovascular events, and there was no imbalance of these events across the two arms. There were no increases from baseline levels in mean daily pain scores or mean total daily opioid dose in either arm. Additionally, there were no reports of opioid withdrawal AEs which could be attributed to Naloxegol. A full assessment of the safety and tolerability findings is ongoing. A New Drug Application (NDA) filing in the US and a Marketing Authorisation Application (MAA) filing in the EU are planned for the third quarter of 2013.