14 oatches approved since 1984

Bioshares have a summary on the recent crystalisation issues for the oxypatch.

Essentially, it semed a little dated considering the announcement recently regarding the new adhesive. They essentially said 3Ms adhesive couldnt hack it but Labtec was devolping one. We know that is done now.

The key to the patch is having consistant delivery, whilst being tamper resistant and robust in various situations and tempuratures.

Trials using 505(b)2 route, are simple. However the trick will be developing a trial that will demonstrate superior performance and less side affects. In order to demonstrate as a better alternative economically.

I think the above have all been sorted. So long as blood oxy levels are constant and patients do not have breakthrough pain then performance will be ticked.

I guess an obvious one would be reduced constipation as a demonstration of reduced side effect.

The tamper proof side of this patch is going to be the big kicker. I wonder how they demonstrate this? Would this be a seperate trial where a group tackle the patch in ways abusers or criminals would?

The most fascinating part was that only 14 patches have been approved in nearly 20 years by the FDA.

High barriers for competitors. I can almost taste success.