BioCentury
ARTICLE | Company News

FDA postpones Relistor meeting

March 1, 2014 1:10 AM UTC

Salix Pharmaceuticals Inc. (NASDAQ:SLXP) disclosed in its 4Q13 and 2013 financial results that FDA postponed a March 10-11 advisory committee meeting to discuss the biotech's appeal of a July 2012 complete response letter for subcutaneous Relistor methylnaltrexone for opioid-induced constipation (OIC) in patients with chronic pain. According to Salix, the postponement is due to "substantial scheduling conflicts." On a conference call to discuss the company's financial results, Salix said it expects the meeting to be rescheduled for "near the end of May."

Relistor, a peripheral mu opioid receptor ( OPRM1; MOR) antagonist, is approved in at least 58 countries, including the U.S., to treat OIC in patients receiving palliative care when response to laxative therapy has not been sufficient. Salix has worldwide rights to Relistor from Progenics Pharmaceuticals Inc. (NASDAQ:PGNX). ...