) recently presented data on naloxegol (25 mg once daily) from
two pivotal phase III studies (KODIAC-04 and -05) at the
Digestive Disease Week (DDW) meeting. Top-line results from this
study were initially presented in Nov 2012.
Naloxegol, a peripherally-acting mu-opioid receptor
antagonist, is being developed for the treatment of
opioid-induced constipation (OIC).
The randomized, double-blind, placebo-controlled studies
evaluated two doses -- 12.5 mg and 25 mg -- of naloxegol. The 25
mg dose met both its primary and secondary endpoints.
In KODIAC-04, both naloxegol doses (12.5 mg and 25 mg)
achieved the primary endpoint. However, in KODIAC-05, although
the 25 mg dose attained the primary endpoint, the 12.5 mg dose
failed to do so. The candidate was found to be safe.
Further plans will be finalized in the coming months.
AstraZeneca had licensed the candidate from
) in Sep 2009.
In Feb 2013, AstraZeneca reported long-term safety data from a
phase III study (KODIAC-08) evaluating the use of naloxegol (25
mg once daily) in patients with non-cancer related pain and
The open-label, randomized, 52-week, long-term safety study,
compared naloxegol with the usual care, a currently available
laxative for OIC. No significant difference was found between
naloxegol and the usual care in terms of serious side effects.
However, adverse side effects like abdominal pain, diarrhea,
nausea and headache were found to be more frequent in patients on
AstraZeneca carries a Zacks Rank #3 (Hold). Currently,
Salix Pharmaceuticals Ltd.
) look more attractive with a Zacks Rank #1 (Strong Buy).
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