AstraZeneca novel constipation drug approved in EU
AstraZeneca’s (AZ) Moventig (naloxegol) has been granted Marketing Authorisation by the European Commission (EC) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxatives.
Developed with Nektar Therapeutics, it is the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) to be approved in the European Union (EU).
Opioids work by binding to mu-receptors in the central nervous system, but they also bind to mu-receptors in the gastrointestinal tract, which can result in OIC.
Approval was based on data from the KODIAC clinical programme. In phase III, the drug was administered as a once-daily tablet and was designed to block the binding of opioids to opioid receptors in tissues such as the gastrointestinal (GI) tract.
The EC marketing authorisation applies to all member states of the EU, Iceland, Norway and Lichtenstein and follows the September approval of the drug in the US as the first once-daily PAMORA for the treatment of OIC in adult patients with chronic non-cancer pain, where it is marketed as Movantik (naloxegol).
Naloxegol, like other drugs in its class, has been linked to an increased risk of heart attacks, so US regulators have asked for a post-market study to monitor any rise in cardiovascular events.
The tablet Movantik will challenge Salix’s Relistor injectable in the US, which had its approval extended in September from treating OIC in cancer patients to treating all those with OIC.
Moventig is part of the 2009 exclusive worldwide licence agreement between AZ and Nektar Therapeutics, which is worth up to $1.5 billion.
Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.