Sandoz to commercialise opioid induced constipation tablet in EU

As it continues to look into drugs that can help opioid-dependant patients, Sandoz has signed an agreement with Shionogi to commercialise 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 is a once-daily 200-microgram oral tablet for the treatment of opioid induced constipation (OIC) in adult patients previously treated with a laxative. Shionogi received EU marketing authorisation for the drug in February.

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

Dr John Keller, CEO of Shionogi’s European subsidiary Shoinogi B.V., said: “Through this contract, we are able to bring together Sandoz’s commercial expertise in Europe, particularly in the field of opioid analgesics with the OIC treatment know-how of Shionogi, which has been developing naldemedine globally. We therefore expect Rizmoic to contribute significantly to OIC treatment in clinical settings in European countries in the future.”

The generics arm of Novartis has been perusing a strategic focus on therapeutic alternatives to combat opioid dependency, which is a growing crisis across the world.

Last year it launched a “digital therapeutic” app with Pear Therapeutics that uses cognitive behavioural therapy to reduce the very high drop-out rates seen among patients in recovery programmes for opioid use.

The app is designed to help people identify the triggers that cause them to relapse and find ways to stop thinking about opioid use, and also helps them stay in outpatient treatment programmes by monitoring their engagement, providing reminders and awarding virtual prizes as a reward for compliance. It was the first drug-paired app to be approved by the FDA.

The company has also signed a potential $293 million agreement to develop and market Durect’s Posimir, an extended-release, locally-acting, non-opioid painkiller in the US.

Rizmoic was originally co-commercialised in the US with Purdue Pharma, but Shionogi regained full rights after Perdue decided to diversify beyond opioid-related drugs in the face of increasing pressure on the area from the FDA.