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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 5 of 5. This is the beginning of the thread.
Posted by michaelroberts on November 28, 2015, at 12:29:46
http://www.medpagetoday.com/Washington-Watch/Washington-Watch/54903
"On Friday, the FDA's Psychopharmacologic Drugs Advisory Committee will review gepirone hydrochloride extended-release tablets for treating depression."
Has anyone heard anything about this? It has been years since Gepirone has been up for review. I'm glad we may finally get a novel treatment for depression without the SSRI side effects.
Posted by SLS on November 28, 2015, at 15:36:18
In reply to Gepirone is Back for Another Round, posted by michaelroberts on November 28, 2015, at 12:29:46
> http://www.medpagetoday.com/Washington-Watch/Washington-Watch/54903
>
> "On Friday, the FDA's Psychopharmacologic Drugs Advisory Committee will review gepirone hydrochloride extended-release tablets for treating depression."
>
> Has anyone heard anything about this? It has been years since Gepirone has been up for review. I'm glad we may finally get a novel treatment for depression without the SSRI side effects.
>Have you tried Brintellix (vortioxetine)? It is similar in effect to gepirone but with added serotonin 5-HT7 receptor antagonism. Of course, each molecule is different. I imagine there will be people who respond to gepirone who would not respond to Brintellix.
- Scott
Posted by michaelroberts on November 29, 2015, at 11:00:48
In reply to Re: Gepirone is Back for Another Round » michaelroberts, posted by SLS on November 28, 2015, at 15:36:18
> > http://www.medpagetoday.com/Washington-Watch/Washington-Watch/54903
> >
> > "On Friday, the FDA's Psychopharmacologic Drugs Advisory Committee will review gepirone hydrochloride extended-release tablets for treating depression."
> >
> > Has anyone heard anything about this? It has been years since Gepirone has been up for review. I'm glad we may finally get a novel treatment for depression without the SSRI side effects.
> >
>
> Have you tried Brintellix (vortioxetine)? It is similar in effect to gepirone but with added serotonin 5-HT7 receptor antagonism. Of course, each molecule is different. I imagine there will be people who respond to gepirone who would not respond to Brintellix.
>
>
> - ScottThanks Scott. The issue with Brintellix is that it is also a serotonin reuptake inhibitor in addition to the 5-HT agonist effect It is the serotonin reuptake inhibition that seems to cause the side effects, just like the rest of the SSRIs. I was hoping that we would finally see something that didn't have all the side effects and wasn't another antidepressant that was also an SSRI.
Looking at recent journal articles on Gepirone, it looks like it has a much better side effect than any antidepressant for sexual dysfunction. It actually has a positive improvement over placebo on sexual dysfunction in both men and women. That is amazing. It strikes me as very odd that the FDA hasn't approved this one.
http://www.ncbi.nlm.nih.gov/pubmed/21324094
http://www.ncbi.nlm.nih.gov/pubmed/22240272
Posted by SLS on November 29, 2015, at 13:12:23
In reply to Re: Gepirone is Back for Another Round, posted by michaelroberts on November 29, 2015, at 11:00:48
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.
- Scott
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
This is the end of the thread.
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