AstraZeneca Reports New Safety Data For Naloxegol In Patients With OIC

(RTTNews) - AstraZeneca Plc. (AZN, AZN.L) announced the results of a Phase III long-term safety and tolerability study of the once-daily 25mg dose of naloxegol, in patients with non-cancer pain and opioid-induced constipation or OIC.

Naloxegol is an investigational peripherally-acting mu-opioid receptor antagonist or PAMORA, which has been studied in OIC in adult patients with chronic non-cancer pain, a common condition caused by prescription opioid pain medicines.

The Phase III study, KODIAC-08 (n=844), was a 52-week, long-term safety trial of naloxegol (n=534) vs. usual care (n=270) in patients with non-cancer related pain and OIC. Usual care was defined as the investigator's choice of an existing laxative treatment regimen for OIC.

The company said that the data from the long-term safety study further support the safety and tolerability of naloxegol, a PAMORA which could help address an unmet need for millions of patients with OIC.

The company noted that data from KODIAC-08 reinforced the safety and tolerability findings from previous Phase III studies, KODIAC-04 and -05.

As per the KODIAC-08 Data, Most naloxegol-emergent gastrointestinal adverse events (AEs) occurred early in treatment and were transient with 9 patients (1.6%) discontinuing naloxegol due to abdominal pain; Most common treatment-emergent AEs occurring more often with naloxegol vs. usual care were abdominal pain (17.8% vs. 3.3%), diarrhoea (12.9% vs. 5.9%), nausea (9.4% vs. 4.1%), headache (9.0% vs. 4.8%), and flatulence (6.9% vs. 1.1%).

The company said there were no imbalances seen in the independently adjudicated cardiovascular events between the two groups - 2 patients in each arm of the study had major adverse cardiovascular events or MACE and these events were not attributed to study drug.

There were two opioid withdrawal AEs reported in patients taking naloxegol (both were attributed to decreases or discontinuation of opioid medication and both were deemed unrelated to treatment with naloxegol).

Pain scores and opioid doses were comparable between treatment groups and were stable throughout the study; No bowel perforations occurred in either group of the study, the company said.