Valeant : Relistor Approved In EU To Treat All Opioid-Induced Constipation

(RTTNews) - Valeant Pharmaceuticals International Inc. (VRX, VRX.TO) and Progenics Pharmaceuticals Inc. (PGNX) 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.

RELISTOR was first approved in Europe in 2008 for the treatment of OIC in advanced illness patients, and is currently approved in more than 50 countries including the United States.

Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Valeant Pharmaceuticals. RELISTOR (methylnaltrexone bromide) subcutaneous injection is a first-in-class treatment for opioid-induced constipation.

RELISTOR (methylnaltrexone bromide) Subcutaneous Injection is contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.