Cardiome Announces Positive Phase 2b Results For Oral Vernakalant
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.
- Published: 14 July 2008
- Written by Editor