Kynapid vernakalant regulatory update

Cardiome said partner Astellas received an SPA from FDA for the double-blind, international Phase III ACT 5 trial to evaluate Kynapid IV vernakalant in about 450 patients with recent-onset atrial fibrillation (AF) without a history of congestive heart failure. The company plans to start the trial in 4Q09, with completion of the trial expected in 1H11. The decision to conduct the study was reached following discussions with FDA to define the regulatory path forward for the product. According to the company, the agency encouraged Astellas and Cardiome to run a prospective trial in this narrower patient population. Cardiome said the Phase III ACT 1 and ACT 3 trials both included heart failure patients, which comprised about 1/3 of the about 900 patients in the trials. ...