CRME:
IMO, what is relevant to cardiome are two things:
1) Rate control is gaining preference over rhythm control. Rhythm control uses drugs like amiodarone and crme's vernakalant, or electrical cardioversion. Rate control uses much more ubiquitous drugs such as beta- and calcium channel blockers.
The largest trial done to compare rate vs rhythm control was the AFFIRM trial which enrolled ~4000 patients in the US and Canada. At five (! - see later note) years, sinus rhythm was better achieved by rhythm control. However, mortality was p = 0.07 in favour of rate control.
Mortality in the next largest such trial, RACE in 522 patients, showed 22.6 vs 17.2% mortality in favour of rate control, despite rhythm control allowing more patients to reach sinus rhythm ~2 years out.
So achieving sinus rhythm is not necessarily an indicator of improved outcomes.
2) The vernakalant trials were placebo controlled, and therefore they were able to handily beat the comparator arm in achieving rhythm. However, this was based on a 1 minute time point, where the majority of the data looking at sinus rhythm are looking 1, 2 and 5 years out.
I do think the side effect profile is better than amiodarone, which is often used for rhythm control. However, these are the pitfalls that i see:
- rate control is generally favored,
- the short duration of the ACT trials,
- a lack of comparison to a standard of care
- the fact that, in a pinch, electrical cardioversion provides better numbers than vernakalant
I think that even with approval, this drug will face an uphill climb to enter the standard of care. Without that, sales will be really, really sluggish imo.
Market Data 
Markets 
AI
