FDA snubs Cardiome's Brinavess resubmission for AF

Cardiome Pharma Corp. (TSX:COM; NASDAQ:CRME) said FDA informed the company that its proposed data package for IV Brinavess vernakalant (Kynapid, MK-6621) to treat atrial fibrillation (AF) would not be sufficient to support resubmission of an NDA.

In 2008, Cardiome received an action letter from FDA regarding the original NDA submission for Brinavess in which the agency requested additional data for the product in patients with symptomatic heart failure, as well as a safety update from ongoing or completed trials. At the time, the company said the letter may result in the need to run an additional trial (see BioCentury, Aug. 18, 2008)...