Viibryd Dose Selection Was Weak Spot, But Sponsor’s Gamble Paid Off
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
“The inadequacy of dose exploration is clearly the ‘Achilles heel’ of this application,” Office of Drug Evaluation I Deputy Director Ellis Unger declared in his Jan. 21, 2011, decision memo for the approval of Clinical Data, Inc.’s antidepressant Viibryd (vilazodone).