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AstraZeneca Reports New Safety Data for Naloxegol, Says Most Naloxegol-Emergent AES Early in Treatment

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AstraZeneca (NYSE: AZN) today 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 (OIC). Naloxegol is an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA), which has been studied in OIC in adult patients with chronic non-cancer pain, a common condition caused by prescription opioid pain medicines. Data were presented at the American College of Gastroenterology (ACG) 2013 Annual Scientific Meeting in San Diego, California.

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 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.” said Kathleen Cantagallo, Clinical VP, naloxegol, AstraZeneca.

Data from KODIAC-08 reinforces the safety and tolerability findings from previous Phase III studies, KODIAC-04 and -05. Data from KODIAC-08 included:

* 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%); * 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 (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.

In addition to the new safety data for naloxegol presented at the 2013 American College of Gastroenterology (ACG) Meeting, there are two additional data presentations for naloxegol at the meeting:

* Tuesday, October 15, Plenary Session 2: Endoscopy/Functional Bowel Disorders; Chey et. al. “Naloxegol Symptom Responder Rates in Patients With Opioid-Induced Constipation: Results From 2 Prospective Randomized Controlled Trials” * Tuesday, October 15, Poster Session: “Chey et. al., “Efficacy of Naloxegol in a Subpopulation of Patients With Opioid-Induced Constipation and an Inadequate Baseline Response to Laxatives: Results From 2 Prospective, Randomized, Controlled Trials”

Posted-In: News FDA

 

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