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Naloxegol Approved for Marketing Throughout European Union
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The European Commission has granted marketing authorization to naloxegol for the treatment of opioid-induced constipation in adult patients with inadequate response to laxatives, according to a press release.
Naloxegol (Moventig, AstraZeneca) is the first once-daily oral peripherally-acting mu-opioid receptor antagonist approved in the European Union, the release said.
“Constipation is one of the most common side effects for those using opioid pain medication,” Briggs Morrison, executive vice president of global medicines development and chief medical officer for AstraZeneca, said in the release. “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.”
This approval follows data from the four studies included in the KODIAC clinical program: two 12-week placebo controlled, double-blind safety and efficacy trials, a 12-week safety extension and a 52-week open label, long-term safety study.
Naloxegol was recently approved by the FDA on September 16, 2014.