Kynapid IV Vernakalant: FDA hold

FDA placed a clinical hold on the Phase IIIb ACT 5 trial of Kynapid IV vernakalant following a single serious adverse event of cardiogenic shock experienced by a Kynapid-treated patient. Astellas has suspended enrollment in the trial. FDA requested to review the full data about the adverse event prior to determining what steps, if any, are needed to restart the trial. The trial's independent DSMB has reviewed the case and recommended the trial continue. Cardiome expects data will be submitted to the agency in the next 2 to 3 weeks. Cardiome also reaffirmed that it still expects to report data from ACT 5 in 1H11.

Astellas, which has North American rights to Kynapid IV, received an approvable letter from FDA in 2008 for the product, in which the agency requested additional data in patients with symptomatic heart failure, as well as a safety update from ongoing or completed trials of vernakalant, including those of the oral formulation (see BioCentury, Aug. 18, 2008). ...