Selegiline transdermal patch

[PsychFuture]

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Has anyone seen the original data from the new drug application that was declined by the FDA for lack of efficacy? I am trying to track it down.

Thanks

 

[sdn1977]

Are you referring to a patch different from the one which was approved in March of this year (EMSAM). It is now approved, but won't be distributed to all wholesalers until later this year.

I asked about this a few months ago...it is effective, but the side effects which limit oral dosing are apparent at all but the lowest patch strength (there are 3 I think) which will limit its usefulness.

It is marketed by Bristol-Meyers Squibb so their site will have the references which were used for approval.

 

[PsychFuture]

I have used the Emsam patch in a couple of patients. I have seen the copy from the FDA of the approve new drug application for the Emsam patch. I am looking for the original application that was declined due to lack of efficacy in 3 out of 4trials that were used to support the new drug application in 2001.

 

[Anasazi23]

I have used the Emsam patch in a couple of patients. I have seen the copy from the FDA of the approve new drug application for the Emsam patch. I am looking for the original application that was declined due to lack of efficacy in 3 out of 4trials that were used to support the new drug application in 2001.

It's likely in the BMS internal data files. Did you try the FDA website?

 

[PsychFuture]

I searched the FDAwebsite and could only find the second approved application and some back and forth about dietary guidelines.

 

[sdn1977]

Try this: search the fda.gov website for the NDA 21336/21708 or do a generic search for selegiline nda history.

The first NDA was submitted by Somerset Pharmaceuticals on 5-24-01 under nda 21-708.

This should get you started on the original studies. Only 1 of the 4 efficacy studies showed positive results for the first nda. I believe they were later redone with more convincing results.