Valeant Pharmaceuticals International Inc. and Progenics Pharmaceuticals Inc. announced that the European Commission has approved Relistor (methylnaltrexone bromide) subcutaneous injection for the treatment of opioid-induced constipation (OIC) when response to laxative therapy has not been sufficient in adult patients, aged 18 years and older.
The decision effective May 27, 2015 is applicable to all 28 European Union member states plus Iceland and Norway and includes an additional one year of marketing protection.
The European Commission decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) which cited that Relistor offers a major contribution to patient care in comparison to existing therapies.
For more details, go to: http://www.nasdaq.com/article/valeant--relistor-approved-in-eu-to-treat-all-opioidinduced-constipation-20150603-00234