A new Opioid-Induced Constipation treatment to be launched in Europe

Sandoz has announced that it has signed an agreement with Shionogi & Co Ltd for the commercialisation of Rizmoic® (naldemedine) in the key European markets of Germany, the UK and the Netherlands, plus right of first refusal for certain other European markets. 

Rizmoic®, a once-daily 200-microgram oral tablet discovered and developed by Shionogi, is an innovative medicine indicated to treat opioid induced constipation (OIC) in adult patients previously treated with a laxative. Shionogi announced on February 22, 2019 that it had received EU marketing authorisation for Rizmoic®.


OIC is a prevalent and distressing side-effect of opioid therapy that does not respond reliably to treatment with conventional laxatives[1].


“Our purpose at Sandoz is to pioneer access by focusing increasingly on differentiated, value-added therapeutics that can make a real difference when it comes to meeting unmet medical needs,” said Francesco Balestrieri, Sandoz CEO a.i.  


He added: “This agreement represents a significant step forward for that strategy and for patients in Europe, reinforcing our long-term commitment to building a leading anti-pain franchise and complementing our portfolio dedicated to minimising the side-effects of opioid use.”


Sandoz has a strong presence in the European market for anti-pain therapeutics, as well as a complementary strategic focus on innovative therapeutic alternatives to combat opioid dependency. This year saw the US launch of two such products, including the first prescription digital therapeutic in this field.


Under the terms of the agreement, Sandoz will be responsible for commercialising Rizmoic® in Germany, the UK and the Netherlands and Shionogi will be responsible for its manufacturing and development. Further details of the deal are not being disclosed.


Naldemedine is a peripherally-acting mu-opioid receptor antagonist (PAMORA) that has been developed by Shionogi as a once-daily treatment for OIC. The efficacy and safety of naldemedine have been evaluated in randomised, double-blind, placebo-controlled studies in adult OIC patients in different countries who have chronic non-cancer pain or cancer. OIC is a change in bowel movements caused by opioid therapy that is characterised by any of the following: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, or harder stool consistency.