Drug news

EU filing of Naloxegol is accepted

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Last updated:27th Sep 2013

Published:27th Sep 2013

Source: Pharmawand

AstraZeneca has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for Naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist, which has been specifically designed for the treatment of Opioid-induced Constipation (OIC) for adult patients 18 years and older, including patients with inadequate response to laxatives.

The MAA filing was based on comprehensive data from the core Phase III KODIAC programme, comprised of four clinical trials designed to investigate the safety and efficacy of naloxegol for the treatment of OIC.

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