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news.Cardiome Pharma has announced top-line results from both the 300mg and 600mg dosing groups for its recently-completed Phase 2a pilot study of oral RSD1235, an investigational drug being evaluated for the treatment of atrial fibrillation.
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For the 300mg dosing group, 61% of patients receiving the drug completed the study in normal heart rhythm, as compared to 43% of all patients receiving placebo, with similar results shown in the 600mg group.
The safety data for both dosing groups suggests that RSD1235 appears well-tolerated, the company said. There were no cases of drug-related Torsades de Pointes, a well-characterized arrhythmia which is an occasional side effect of some current anti-arrhythmic drugs, Canada-based Cardiome added.
“This clinical trial has exceeded our expectations, reinforcing the signal we saw in the 300mg interim results and giving us an even greater degree of confidence in the potential for RSD1235 (oral) as a therapy for the prevention of recurrence of atrial fibrillation,” said Bob Rieder, CEO of Cardiome.