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July 3, 2012
12:29 EDTCRMECardiome says CEO Doug Janzen has left company
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November 17, 2014
08:38 EDTCRMECardiome enters commercialization agreement with Aspen for BRINAVESS
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November 7, 2014
07:09 EDTCRMECardiome submits Brinavess reimbursement dossier to Italian authorities
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07:09 EDTCRMECardiome announces positive results from Brinavess clinical trial
Cardiome announced results from a Phase 3 clinical study conducted with BRINAVESS in the Asia-Pacific region. The study was originally planned to recruit 615 patients, however the study was completed after randomising 123 patients. The study remained sufficiently powered and it achieved the primary endpoint, showing that of the 111 treated patients with recent-onset atrial fibrillation lasting 3 hours to 7 days, 53% of those receiving an IV dose of BRINAVESS converted to normal heart rhythm within 90 minutes, compared to 12% of placebo patients. The A-P study data suggests that BRINAVESS was generally well-tolerated in the targeted patient population. In the 30 day interval following drug administration, serious adverse events occurred in 6 placebo patients and 7 patients dosed with BRINAVESS. Potentially drug-related serious adverse events occurred in 1 patient receiving BRINAVESS. There were no cases of drug-related torsades de pointes, a well-characterized arrhythmia which is an occasional side effect of many current antiarrhythmic drugs.
07:08 EDTCRMECardiome reports Q3 EPS (26c), consensus (13c)
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