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:
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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;
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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%);
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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;
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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);
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Pain scores and opioid doses were comparable between treatment groups
and were stable throughout the study;
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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:
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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”
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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”
NOTES TO EDITORS
About Naloxegol
Naloxegol is an investigational peripherally-acting mu-opioid receptor
antagonist (PAMORA), which has been specifically designed for the
treatment of opioid-induced constipation (OIC), a condition caused by
prescription opioid pain medicines. Naloxegol is a once-daily tablet
designed to block the binding of opioids to the opioid receptors in the
gastrointestinal (GI) tract without impacting the opioid receptors in
the brain.
Naloxegol is part of the exclusive worldwide license agreement announced
on 21 September 2009, between AstraZeneca and Nektar Therapeutics
(NASDAQ:NKTR). Naloxegol was developed using Nektar’s oral small
molecule polymer conjugate technology.
About Opioid-Induced Constipation
Opioids bind to specific proteins called opioid receptors. When the
opioids bind to certain opioid receptors in the gastrointestinal (GI)
tract, constipation may occur. Opioid-induced constipation (OIC) is a
result of increased fluid absorption and lower GI motility due to opioid
receptor binding in the GI tract.
Globally, approximately 40–50% (28-35 million) of patients taking
opioids for long-term pain develop OIC. About 40–50% (11-18 million) of
those OIC sufferers achieve the desired treatment outcomes with current
options that include over-the-counter and prescription laxatives.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of cardiovascular,
metabolic, respiratory, inflammation, autoimmune, oncology, infection
and neuroscience diseases. AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
For more information please visit: www.astrazeneca.com
2919400 Last Updated 10/13
Copyright Business Wire 2013