Gepirone ER

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sdn1977

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The most recent info is of Feb 8 of this year - a few days ago.

Some history - in June 2004, the FDA determined Gepirone ER was not approvable. Fabre-Kramer Pharmaceuticals (a privately held specialty pharmceutical company) re-acquired all rights to it from Organon, assuming Organon would continue its responsibility for ongoing pediatric trials. At that time, if the FDA approved it in the future, Organon would receive a milestone payment & also receive royalties based on future sales.

Now...as of Feb 8 of this year...GSK & Fabre-Kramer announced an eclusive worldwide agreement which is expected to be submitted to the FDA for approval in this quarter. The agreement includes development & commercialisation as well as development opportunities for follow-up products (the "me-too's").

The terms of the agreement are confidential, but again, FKP will receive an upfront payment as well as milestone payments based on NDA approval & launch of the product.

Fabre-Kramer is based in Houston, TX & the contact there for US development is Tom Curry - 215-751-7002.

That's all I know - sorry - not too much!
 

Anasazi23

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That's interesting info. It's so rare for a psych med to be tested on a peds population before it comes out. You can see where this marketing niche is going very easily.

Not that it's about that solely. It really is a shame that more meds can't get a peds research base prior to its release, since there's a high chance it will end up in them anyway at some point.
 

sdn1977

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That's interesting info. It's so rare for a psych med to be tested on a peds population before it comes out. You can see where this marketing niche is going very easily.

Not that it's about that solely. It really is a shame that more meds can't get a peds research base prior to its release, since there's a high chance it will end up in them anyway at some point.

Its expensive & high risk research, with very little reward since, as you pointed out - it will be used in that population off label.

If a drug has inidcations or dosage ranges for children <12....there must be research documenting it - epxpensive!

Post marketing surveillance brings forward the adverse events in this population (SSRIs for example)...whcih then brings forth black box warnings, rather than pre marketing guidelines which might have provided insight into susceptible populations rather than complete age groups.
 

sdn1977

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I don't have details...but I think it had to do with statistical signifance of the outcomes.

I really can't remember if it was study design, numbers of pts enrolled, or any other things that can possibly go wrong in study submission. I really haven't followed it very closely since I'm not in a study site.

Obviously, it was significant enough to have another company purchase its options....
 
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