Cardiome Pharma Corp announced that its co-development partner, Astellas Pharma US., Inc, has suspended patient enrolment in the ACT 5 study of Kynapid (vernakalant hydrochloride) Injection following a single unexpected serious adverse event of cardiogenic shock experienced by a patient with atrial fibrillation who received Kynapid.
The trial’s independent Data Safety Monitoring Board (DSMB) has reviewed the case and recommended the trial continue, however the US Food and Drug Administration (FDA) has requested that full data regarding this case from the South American clinical site be provided for their review prior to determining what steps, if any, are needed to restart the study.
“Patient safety has been and continues to be the primary concern of both Cardiome and Astellas,” stated Doug Janzen, president and CEO of Cardiome. “We and Astellas will work closely with the clinical trial site, the DSMB and the FDA to review this serious adverse event, and seek to resume patient enrollment and treatment in the ACT 5 study as soon as it is appropriate to do so.”
Cardiome Pharma Corp is a product-focused drug development company dedicated to the advancement and commercialization of novel treatments for disorders of the heart and circulatory system.