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news.AstraZeneca has received marketing authorization from the European Commission (EC) for Moventig (naloxegol) to treat opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
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Moventig is the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) to be approved in the European Union (EU).
The approval was based on data from the KODIAC clinical program, which included four trials KODIAC-4, -5, -7 and -8.
Both KODIAC-4 and -5 were placebo controlled, double-blind, 12 week trials evaluating safety and efficacy, while KODIAC-7 was a 12 week safety extension to KODIAC-4, and KODIAC-8 was a 52 week open label, long-term safety trial.
Opioids play a major role in chronic pain relief and work by binding to mu-receptors in the central nervous system (CNS), but they also bind to mu-receptors in the gastrointestinal tract, which can result in patients suffering from OIC.
AstraZeneca executive vice-president Global Medicines Development and chief medical officer Briggs Morrison said: "Constipation is one of the most common side effects for those using opioid pain medication.
"We’re very pleased to have received marketing authorization for Moventig, as it allows us to offer a new treatment option for the millions of patients across Europe who suffer from opioid-induced constipation and haven’t responded to laxatives."
The European marketing authorization applies to all member states of the EU, Iceland, Norway and Lichtenstein.
In September 2014, Movantik (naloxegol) tablets were approved by the US Food and Drug Administration (FDA) as the first once-daily PAMORA for the treatment of OIC in adult patients with chronic non-cancer pain.
Image: AstraZeneca headquarters in London, UK. Photo: courtesy of AstraZeneca plc.