Posted by Michael Wonder on 24 Feb 2019
Shionogi receives European Union marketing authorisation for Rizmoic (naldemedine) for the treatment of opioid-induced constipation in adults previously treated with a laxative
22 February 2019 - The EC’s approval of Rizmoic is based on data from three Phase 3 efficacy and safety studies (V9231, V9232 and V9236) and one long-term safety study (V9235).
Shionogi announced today that the European Commission (EC) has granted marketing authorisation for Rizmoic (naldemedine), for the treatment of opioid-induced constipation in adult patients who have previously been treated with a laxative.
This decision by the EC has followed adoption of the positive opinion of the CHMP in December 2018.
