AstraZeneca (AZN) 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 Nektar Therapeutics (NKTR) 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 OIC.
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 naloxegol.
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