Positive results in Phase III trials of Naloxegol (AstraZeneca) for patients with Opioid Induced Constipation

Two Phase III trials and one safety extension trial of Naloxegol (naxolol), from AstraZeneca, in patients with non-cancer related pain and Opioid Induced Constipation (OIC) indicates that Naloxegol demonstrated statistically significant results for the primary endpoint, defined as having at least three Spontaneous Bowel Movements (SBM) per week, with at least one SBM per week increase over baseline. KODIAC-04 and -05 are both multicenter, randomized, double-blind, placebo-controlled pivotal trials of 12 weeks duration evaluating 12.5 mg and 25 mg Naloxegol administered once-daily. The analyses showed no clinically relevant imbalances in serious adverse events (SAEs), including externally adjudicated major cardiovascular events, across the three treatment arms in KODIAC-04, -05 and -07.

The most common adverse events (AEs) in the Naloxegol treatment arms in both trials were abdominal pain, diarrhea and nausea. In KODIAC-07, (the safety extension of KODIAC-04) the occurrence of AEs and SAEs was lower than in KODIAC-04 and -05. Enrolment is complete for the open-label, randomized, 52-week long-term safety trial (KODIAC-08) and the trial is expected to be completed by Q1 2013.