ARYX - Buriodarone:
Have done some of the DD to compare it to existing treatments and I would suggest that Budiodarone has two significant hurdles:
1) It still shows hints of many of the toxicities seen for Amiodarone - more in fact than Dronedarone (another Amiodarone redo - but with lesser efficacy than Amiodarone). (Note the word 'hints' because from the data released so far it is hard to tell anything other than that it probably still has some kind of tox for thyroid and liver - both of which are significant for Amiodarone, although I can't, for instance, find median blood data for such Amiodarone SAEs) In contrast Vernakalant(sp?) appears to have fewer side effects.
2) The endpoint they used in the ph ii is technically really cool because it offers stat sig on a very small trial. But it is a very non-standard endpoint. I could find only one other drug trial that used a similar endpoint (Azilimide - which obtained a 40% reduction in burden, albeit with a substantially different patient population. And note that Azilimide is probably one of the pack (i.e. less efficacious than Amiodarone) - but it offers a weak comparison)) In contrast Vernakalant(sp?) used a much more traditional endpoint which is more comparable and appears to be competitive with Amiodarone in efficacy (based upon median times to return of AF).
All total I'd expect ARYX to get substantially less then CRME did. Maybe 1/2? But I'll acknowledge large uncertainty bounds.
Comments welcome.