Cardiome Announces Positive Phase 2b Results For Oral V...( NASDAQ: CR...),Health

NASDAQ: CRME TSX: COM

VANCOUVER, July 14 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced positive clinical results from its 90-day Phase 2b study of vernakalant (oral). The final analysis demonstrated statistically significant efficacy for the patient group receiving 500mg b.i.d. of vernakalant (oral) as compared to placebo. The safety data from the final analysis also shows that vernakalant (oral) was well-tolerated in the atrial fibrillation population studied.

The final results demonstrated that the 500mg dosing group significantly reduced the rate of atrial fibrillation relapse as compared to placebo (two-sided log rank, p=0.0221). The median time to recurrence of atrial fibrillation was greater than 90 days for the 500mg dosing group, compared to 27 days for the placebo group, an even stronger signal of sinus rhythm maintenance than what was seen in the interim analysis. 51% of patients in the 500mg dosing group (n=150) completed the study in normal heart rhythm compared to 37% of patients receiving placebo (n=160). Both the 150mg (n=147) and 300mg (n=148) dosing groups also reduced the rate of atrial fibrillation relapse, but were not statistically significant when compared with placebo. These results provide evidence of a clear dose response, with 500mg b.i.d. proving to be the effective dose to prevent the recurrence of atrial fibrillation in this trial.

"These statistically significant and clinically significant results support and enhance the results we saw in the interim analysis and Phase 2a study, while clearly demonstrating an appropriate dose to take forward into the Phase 3 program," said Dr. Charles Fisher, Executive Vice President and Chief Medical Officer of Cardiome. "Having observed more than a threefold increase in median time to recurrence of atrial fibrillation in patients receiving 500mg b.i.d. of vernakalant (oral), the potential therapeutic benefit
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