Encouraging results for AstraZeneca's naloxegol in OIC

Anglo-Swedish drug major AstraZeneca (LSE: AZN) has announced high-level results from KODIAC-08, an open-label, randomized, 52-week, long-term safety trial of naloxegol versus usual care (UC) in patients with non-cancer related pain and opioid-induced constipation (OIC), demonstrating no imbalances in serious side effects.

UC was defined as the investigator’s choice of an existing laxative treatment regimen for OIC. This is the fourth trial in the naloxegol Phase III development program, and was designed to evaluate the long-term safety and adverse event (AE) profile of naloxegol in patients taking 25mg once daily, as compared to UC.

In the trial, a total of 534 patients received naloxegol once daily for up to 52 weeks, while 270 patients received UC for OIC during the same treatment period. The most commonly reported AEs occurring more frequently on naloxegol than on usual care included abdominal pain, diarrhoea, nausea and headache. The trial reported no imbalances in serious adverse events (SAEs). In addition, there were a low number of major adverse cardiovascular events (MACE), as adjudicated by an independent external committee, and there was no imbalance of these events across naloxegol and UC arms.