BioCentury
ARTICLE | Company News

FDA to hold Relistor panel

June 12, 2013 1:05 AM UTC

Salix Pharmaceuticals Inc. (NASDAQ:SLXP) said FDA will convene an advisory committee meeting to discuss the biotech's appeal of a complete response letter for subcutaneous Relistor methylnaltrexone to treat opioid-induced constipation (OIC) in patients with chronic pain. Salix said FDA requested additional clinical data in the July 2012 letter, but the company believed existing data were sufficient for approval of the sNDA. Salix said a conclusion on the appeals process could be reached this year; though a meeting date has not yet been set (see BioCentury Extra, May 9).

Salix expects the panel to discuss the available safety data for Relistor, a peripheral mu opioid receptor ( OPRM1; MOR) antagonist, and the strength of a cardiovascular safety signal seen with another drug in the class. Salix also expects discussion of the potential for MOR antagonists to trigger withdrawal symptoms and the need for and timing of major cardiovascular events (MACE) studies. Salix said FDA indicated it will seek advice from pain, gastrointestinal, safety and cardiovascular experts. ...