ARTICLE | Company News

Cardiome falls on IV vernakalant hold

October 22, 2010 12:31 AM UTC

Shares of Cardiome Pharma Corp. (TSX:COM; NASDAQ:CRME) slid after FDA placed a clinical hold on the Phase IIIb ACT 5 trial of Kynapid IV vernakalant to treat atrial fibrillation (AF) following a single serious adverse event of cardiogenic shock experienced by a Kynapid-treated patient. Partner Astellas Pharma Inc. (Tokyo:4503) suspended enrollment in the trial. FDA requested to review 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 two to three 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 Kynapid IV, 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. Cardiome was down C$0.71 (11%) to C$5.79 on Thursday. On NASDAQ, the stock fell $0.68 (11%) to $5.69. ...