Posted by michaelroberts on November 29, 2015, at 14:53:18
In reply to Re: Gepirone is Back for Another Round, posted by SLS on November 29, 2015, at 13:12:23
> Is this the third round?
>
> It was my impression that Brintellix was not very potent as a serotonin reuptake inhibitor, and not as prone as SSRIs at producing sexual side effects. Gepirone would be a great drug to become available. I was very disappointed when it was rejected by the FDA.
>
>
> - ScottScott, it didn't say what round in the news article, but I pulled up the FDA website and everything is listed there for the gepirone public hearing on December 1--including all the internal FDA memos. Based on the below link to the FDA brief, gepirone is up for a 4th time. That is a lot of times--is that normal? Regardless, it looks like the same person at the FDA turned it down each of those three times, in 2002, 2004, and 2007. This is the first appeal to a different reviewer, so hopefully gepirone will get an unbiased review from the FDA Advisory Committee. Also, it looks like another department in the FDA supports approval. So, it appears that there is disagreement within the FDA--amazing.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM474540.pdf
poster:michaelroberts
thread:1084249
URL: http://www.dr-bob.org/babble/20151119/msgs/1084277.html