Relistor methylnaltrexone regulatory update

Salix and Progenics said EMA accepted for review an application to expand the label of subcutaneous Relistor methylnaltrexone to treat opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. Salix is appealing a July 2012 complete response letter from FDA for subcutaneous Relistor in the indication. An advisory committee meeting is tentatively scheduled for June 11-12 to discuss the biotech's appeal (see BioCentury, June 17, 2013 & Feb. 28, 2014). ...