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news.Valeant Pharmaceuticals and Progenics Pharmaceuticals have received approval from the European Commission for Relistor (methylnaltrexone bromide) subcutaneous injection to treat opioid-induced constipation (OIC).
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Relistor is indicated for OIC treatment when response to laxative therapy has not been sufficient in adult patients, aged 18 years and older.
The approval of Relistor is applicable to all 28 European Union (EU) member states as well as Iceland and Norway.
Progenics has exclusively licensed development and commercialization rights for its first commercial product, Relistor, to Valeant.
Progenics CEO Mark Baker said: "This approval represents a milestone for the Relistor franchise, significantly expanding the number of patients in Europe who can benefit from this drug.
"OIC can be a tremendous burden, affecting a patient’s ability to function adequately, but Relistor provides patients with the ability to effectively treat their symptoms. Importantly the European approval also recognized the benign safety profile of Relistor."
In Europe, Relistor was first approved in 2008 to treat OIC in advanced illness patients, and is currently approved in over 50 countries including the US.