Posted by law663 on December 6, 2005, at 23:38:08
In reply to The frustrations of waiting for EMSAM, posted by RobertDavid on December 6, 2005, at 22:23:56
It will come out. The FDA has ruled on the dietary restirction issue. The FDA is netoriously risk adverse, leading to obvious type II errors. If the FDA allows a drug on the market and it kills people, there's political hell to pay. But if it disallows a drug, there is little repercussion for all those that drug would have helped. Look at Vioxx: Hardly anyone speaks about the numerous people who are without a great drug despite the flimsy evidence that it was harmful.
That said, I think there's a good shot that Emsam will be out soon. Then we'll see if it lives uo to all of the hype.
> I was disapointed to hear that news about further delays last month. I've been dying to be a "guinea pig", be first in line to try it. My doc thinks it's going to be great for many treatment resistent patients.
>
> Gosh, it's been in the works since the late 90's. I've read many posts from people like Adam who responded so well to the patch (I wonder how he's doing, if he's still taking oral selegiline). There was so much excitement about a new option.
>
> Who would have thought it would take this long to get a decision about an already approved drug, just delivered via a patch. Perhaps this is the end of the road and there will be an actual thumbs up or down in February. I understand it all just comes down to the food restriction requirements on the labeling.
>
> If it's approved without the need to warn about food interaction BM & Mylan will probably work to make it available quickly. If they need to put food restriction warning on it I wonder if they will push it at all.
>
> I sure wish there was a way to get something other than lip service from the FDA and drug companies about the approval status/process. Everyone I've talked with acts like they know the scoop, just say it. Like it's some big secret.
>
> If it does come out, I just hope it will have been worth the wait, at least for some who haven't had luck with other meds.
poster:law663
thread:585987
URL: http://www.dr-bob.org/babble/20051203/msgs/586322.html